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Diss Factsheets

Administrative data

Description of key information

Skin irritation
Both reliable studies, the in-vitro and the in-vivo one assessed the test items as non-irritant. In the in-vivo study only very slight erythema was observed in one animal and only at the day of substance application. In the in-vitro one the mean value of relative tissue viability was increased to 101.3 % (mean of three replicates).


 


Eye irritation
Eight zeolites were tested for eye irritation. Five of them were assessed as non-irritant, three as slightly and reversible irritating by the authors. But only one of these three fulfills the criteria for classification according to table 3.3.2 of the GHS (2019). However, the eye irritating effects observed in this study may have been caused by an excess of caustic soda during the manufacturing process, which was not completely removed during subsequent washing processes and led to the extreme pH of 11.6. Therefore, this study is not reliable.


In this study the single application of 0.1 gram of a type A zeolite into one conjunctival sac each of three rabbits caused only slight changes. In all animals, 24 hours after application of the test substance, the cornea showed slight diffuse opacity (rating 1) over the entire surface which had only completely subsided on the eighth day after treatment. The iris showed slight hyperemia in one animal after 24 and 48 hours (rating 1). The conjunctiva reacted in all animals immediately after application with diffuse, flesh-colored reddening (rating 3) and swelling with partial swelling or everted (2 animals) or half-closed (1 animal) lids (rating 2 and 3). These findings completely subsided at the latest on the 6th day of observation. The irritation index was 25. According to this, the tested type A zeolite has slightly irritating properties on the rabbit's eye. According to table 3.3.2 of the GHS (2019) this would fulfill the criteria for classification category 2A, if the study were reliable.


Another type A zeolite was considered slightly irritating to the monkey eye, because signs of eye irritation consisted of corneal dullness and slight conjunctival redness in both eyes at 24 hours. All signs of eye irritation had subsided completely by 48 hours. According to table 3.3.2 of the GHS (2019) this does not fulfill the criteria for classification.


Following administration of 60 mg (0.1 ml) of a type X zeolite, based on 24-hour findings and by FHSA definition, 4 eyes were positive for corneal injury, iritis and conjunctival irritation. Therefore, the substance was an FHSA irritant. All eyes were healed after 72 hours. After instillation of 10 mg, no eyes developed corneal opacity or iritis. According to table 3.3.2 of the GHS (2019) this does not fulfill the criteria for classification.


In conclusion, all reliable studies did not fulfill the criteria for classification. Five of eight studies were even assessed as non-irritant

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jul. 16 -Sep. 16, 2019; experimental phase: Aug. 19-23, 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
2019-06-18
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Name: Rive Zeolite (crystalline aluminosilicate)
Batch no.: R - W0170316
Appearance: beige-brown powder
Composition: Zeolite (crystalline aluminosilicate), treated with acid; water
Purity: not applicable, mixture
Homogeneity: homogeneous
Expiry date: Oct. 2021
Storage: Room Temperature (20 ± 5 °C)
CAS No.: 1318-02-1
EC-No.: 215-283-8
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Details on animal used as source of test system:
The test system is a commercially available EpiDerm-Kit, procured by MatTek.
The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have been cultured to form a multi-layered, highly differentiated model of the human epidermis. It con-sists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers representing main lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on specially prepared cell culture inserts.
Vehicle:
other: DPBS buffer
Details on test system:
One valid experiment was performed.
Three tissues of the human skin model EpiDermTM were treated with the test item for 60 minutes.
The test item was applied directly to each tissue and spread to match the tissue size (0.63 cm²; as indicated by the supplier).
DPBS-buffer was used as negative control and 5% SDS solution was used as positive control.
Control samples:
yes, concurrent vehicle
yes, concurrent positive control
Amount/concentration applied:
24.6-24.8 mg
Duration of treatment / exposure:
60 min
Duration of post-treatment incubation (if applicable):
23 h 25 min
Number of replicates:
3
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
tissue 1 to 3
Value:
ca. 96 - ca. 104.8
Vehicle controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
mean
Value:
101.3
Vehicle controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
After the treatment with the test item, the mean value of relative tissue viability was increased to 101.3 % (SD: 4.7%). This value is above the threshold for skin irritation potential (50%). Test items that induce values above the threshold of 50% are considered non-irritant to skin.
Tissue viability tissue 1: 96.0%; Tissue viability tissue 2: 103.1%; Tissue viability tissue 3: 104.8%

After treatment with the negative control, the mean absorbance value was within the re-quired acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 1.7.
The positive control showed clear irritating effects. The mean value of relative tissue viability was reduced to 2.3 % (required: ≤ 20%).
The variation within the tissue replicates of negative control, positive control and test item was acceptable (required: ≤ 18%).
Conclusions:
The test item Rive Zeolite was considered non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Method. The mean value of relative tissue viability was increased to 101.3 % (mean of three replicates).
Executive summary:

This in vitro study was performed in order to evaluate the potential of Rive Zeolite to evoke skin irritation in a reconstructed human epidermis (RhE) test method.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jun. 22 - Oct. 15, 1990; experimental phase: Jul. 3-13, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
yes
Remarks:
Temperature fell for short periods down to 18° C; this deviation did not influence the validity of the study.
Principles of method if other than guideline:
The method based on the OECD Guideline No. 404 and the EEC Guideline 84/449/EEC.
The irritation index on the intact skin was assessed by a modified method according to Gilman et al.
GLP compliance:
yes
Specific details on test material used for the study:
Name/Identity: Wessalith AP 400 (A Zeolite)
Chemical Name/Synonym: Sodium-aluminiumsilicate
CAS No.: 1344-00-9
Batch No.: 89/100
Physical Appearance: Whi te powder
Content/Purity: No known impurities
Solubility: Insoluble in water
pH-Value: Approx. 10 (suspension)
Storage: The test substance was kept in an exsiccator in a refrigerator.
Stability: According to information from the sponsor, the test substance was stable throughout the experimental period.
Species:
rabbit
Strain:
other: White Russian (Albino)
Details on test animals or test system and environmental conditions:
Origin/Breeder: ASTA Pharma AG, Bielefeld, Germany
Age of the Animals at Treatment: Males 10, 11 months; female 11 months
Body Weight of the Animals at Treatment: Males 2.27, 2.50 kg; female 2.35 kg
Total Number of Animals: 3; 2 males and 1 female
Caging: : Stainless steel cages with grating floor, type ASTA, size: 48.5x40x36.5 cm
Number of Animals per Cage: 1
Diet: Approx. 120 gram/day x animal, standard diet ssniff K
Water: ad libitum
Room Temperature: 20 - 22.5° C (for short periods down to 18° C; this deviation did not influence the validity of the study)
Relative Humidity: 40 - 70 %
Room Lighting: 6 a.m. - 6 p.m. artificial lighting, 6 p.m. - 6 a.m. natural light-dark-rhythm

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
demineralized
Controls:
yes, concurrent vehicle
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
The application sites were clipped free of hair one day before treatment.
To avoid deprivation, 0.5 gram of the test substance were moistened with 0.5 ml demineralized water and placed on the shorn dorsal skin area between shoulder and sacrum. The site of application was covered with a linen cloth (approx. 6.25 cm²) which adhered to a synthetic film glue. The opposite area of the dorsal skin was treated in the same way but without test substance (control site). A bandage wrapped several times around the trunk (Acrylastic, No. 2408, width 8 cm; supplied by P. Beiersdorf and Co. AG, Hamburg) provided a complete occlusion. After the end of the exposition time remaining test material was gently washed off as far as possible.
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
8
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
8
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 h
Score:
1
Max. score:
8
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
8
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
8
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
8
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
8
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
8
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Max. score:
8
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
8
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
8
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
8
Irritant / corrosive response data:
The observed skin reaction was:
Erythema:: Very slight erythema (one animal)
The finding was observed only at the day of substance application.

The primary irritation index was 0.1.
Wessalith AP 400 was classified as non-irritant on the skin of the rabbit.
Other effects:
Systemic-toxic effects did not occur after dermal application of the test substance. The general condition of the test animals was not affected.
Conclusions:
The observed skin reaction was:
Erythema:: Very slight erythema (one animal)
The finding was observed only at the day of substance application.

The primary irritation index was 0.1.
Wessalith AP 400 was classified as non-irritant on the skin of the rabbit.
Executive summary:

The objective of the study was to investigate the primary irritant/ corrosive properties of wessalith AP 400. They were determined after single application of the test substance to the intact dorsal skin of rabbits for four hours under occlusive conditions. Attention was additionally paid to the occurrence of systemic toxic effects.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jul. 4 - Oct. 15, 1990; experimental phase: Jul. 10-20, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
not specified
GLP compliance:
yes
Specific details on test material used for the study:
Test Substance/ Trade Name/Identity: Wessalith AP 400 (A Zeolite)
Chemical Name/Synonym: Sodium-aluminiumsilicate
CAS No.: 1344-00-9
Batch No.: 89/100
Physical Appearance: White powder
Content/Purity: No known impurities
Solubility: Insoluble in water
pH-Value: Approx. 10 (suspension)
Storage: The test substance was kept in an exsiccator in a refrigerator.
Stability: According to information from the sponsor, the test substance was stable throughout the experimental period.
Species:
rabbit
Strain:
other: White Russian (albino)
Details on test animals or tissues and environmental conditions:
Origin/Breeder: ASTA Pharma AG, 4800 Bielefeld; Germany
Age of the Animals at Treatment: 11 months
Body Weight of the Animals at Treatment : 2.77 - 3.00 kg
Caging: Stainless steel cages with grating floor, type ASTA, size: 48.5x40x36.5 cm (LxBxH)
Number of Animals per Cage: 1
Diet: Approx. 120 gram/day x animal; Standard Diet ssniff K, "Special diet for rabbits"
Water: Water was provided ad libitum in drinking water quality
Room Temperature: 18 - 22° C
Relative Humidity: 40 - 70 %
Room Lighting: 6 a.m. - 6 p.m. artificial lighting 6 p.m. - 6 a.m. natural light-dark-rhythm

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.09 g (c. 0.1 ml)
Duration of treatment / exposure:
once (unrinsed)
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
0.09 gram (representing a volume of about 0.1 ml) of the test substance were applied into the conjunctival sac of the right eye. Then both lids were briefly closed by gentle finger pressure. The other eye of each animal was not treated and acted as control. The treated eye was not rinsed.
The treated eye was examined using a Cliptrix pencil light. Signs of irritation on the cornea, iris, and conjunctiva were assessed quantitatively and qualitatively using the Draize scale
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 h
Score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritant / corrosive response data:
The single application of 0.09 gram (representing a volume of about 0.1 ml) Wessalith AP 400 into one conjunctival sac each of three rabbits caused only slight changes. Because of the physical properties of the test substance the dose had to be limited to the a.m. level.
In the cornea and iris no alterations were detectable.
The conjunctiva of one animal reacted with hyperemia (grade 1). 24 hours after application the finding had completely disappeared.
Discharge occurred in all three animals only at the day of application. In two animals discharge moistened considerable areas around the eye (grade 3) and in one animal lids and hair just adjacent to lids (grade 2).
The irritation index was 2.

Other effects:
There were no systemic toxic effects after conjunctival application of the test substance. The general condition of the animals was undisturbed.
Interpretation of results:
GHS criteria not met
Conclusions:
The primary irritation index was 2.
Wessalith AP 400 was classified as non-irritant on the eye of the rabbit.
Executive summary:

The objective of the study was to indicate the possible existence of hazards likely to arise from exposure of the eyes and associated mucous membranes to Wessalith AP 400. Alterations of cornea, iris, and conjunctiva and any other changes as well as the progress of the lesions (and their reversibility or irreversibility) had to be observed and recorded. Attention was additionally paid to the occurrence of systemic toxic effects.

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jul. 19 - Sep. 20, 2019; experimental phase: Aug. 19 - Sep. 12, 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
Version / remarks:
2019-06-18
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Name: Rive Zeolite (crystalline aluminosilicate)
Batch no.: R - W0170316
Appearance: beige-brown powder
Composition: Zeolite (crystalline aluminosilicate), surface-treated with acid; water
Purity: not applicable, mixture
Homogeneity: homogeneous
Expiry date: Oct. 2021
Storage: Room temperature (20 ± 5 °C)
CAS No.: 1318-02-1
EC-No.: 215-283-8
Species:
human
Strain:
other: artificial
Details on test animals or tissues and environmental conditions:
human cornea tissue model
Vehicle:
other: MTT stock solutiom
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
49.8 (replicate 1) and 51.5 (replicate 2) mg
Duration of treatment / exposure:
6 hours
Duration of post- treatment incubation (in vitro):
18 hours
Number of animals or in vitro replicates:
2
Details on study design:
The test item Rive Zeolite was applied to a three-dimensional human cornea tissue model in duplicate for an exposure time of 6 hours.
After treatment, the respective substance was rinsed from the tissue; then, cell viability of the tissues was evaluated by addition of MTT, which can be reduced to formazan. The form-azan production was evaluated by measuring the optical density (OD) of the resulting solution.
Demineralised water was used as negative control and methyl acetate was used as positive control.
Irritation parameter:
in vitro irritation score
Run / experiment:
second (valid) experiment
Value:
ca. 93.2 - ca. 93.8
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The controls showed the following results: After treatment with the negative control, the ab-sorbance values were within the required acceptability criterion of mean OD > 0.8 and < 2.5, OD was 1.8. The positive control showed clear eye irritating effects, the mean value of the relative tissue viability was 44.0 % (< 50%).
The variation within tissue replicates of the controls and the test item was acceptable (< 20%).
After treatment with the test item, the mean value of relative tissue viability was 93.5 %.
This value is above the threshold for eye irritation potential (≤ 60%). Test items that induce values above the threshold are considered non-eye irritant.
Conclusions:
Under the conditions of the test, Rive Zeolite was considered non-eye irritant in the EpiOcular Eye Irritation Test. The mean viability was 93.5%.
Executive summary:

This study was performed in order to evaluate the eye hazard potential of Rive Zeolite in a Reconstructed human Cornea-like Epithelium (RhCE) model in an in vitro study (e.g. Epi-OcularTM Eye Irritation Test).

Endpoint:
eye irritation: in vivo
Type of information:
other: assessement report
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Interpretation of results:
GHS criteria not met
Conclusions:
Based on all available data, there were no indications of substance-intrinsic eye irritating properties for non-ion-exchanged Zeolites. This conclusion assumed that no caustic soda was still present in the substance as a residue from the manufacturing process and that the cation-exchange capacity of the Zeolites was low.
Executive summary:

Five standard animal studies were evaluated with regard to OECD testing guideline 405 (2020).
One study (The Procter & Gamble Company, 1974) was considered invalid and not suitable for classification purposes. The results of the study by W. R. Grace and Company (1976) were considered inconclusive due to deficiencies in study execution and documentation when compared to current testing guidelines, but could be used as supporting information.
The remaining three studies (Degussa AG, 1988; Union Carbide Corporation, 1988; Tosoh Corporation, 1989), were considered reliable with restrictions, gave considerably different, even contradictory results. Therefore, as recommended by UN-GHS (8th revision, 2019), a weight-of-evidence approach was carried out, considering all available data.
Based on all available data, there were no indications of substance-intrinsic eye irritating properties for non-ion-exchanged Zeolites. This conclusion assumed that no caustic soda was still present in the substance as a residue from the manufacturing process and that the cation-exchange capacity of the Zeolites was low.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
somewhere between Oct. 8 (substance recieved) and Dec. 10 (report dated), 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
two monkeys, one dose level, without rinsing, 7-day observation time
GLP compliance:
not specified
Specific details on test material used for the study:
Identification: UDL 812 (A Zeolite)
Dcscription: A fine white powder with a faint odor
Date Recieved: Oct. 8, 1974
Purity: Assumed 100% active ingredients.
Species:
monkey
Strain:
other: Rhesus
Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml (c. 35 mg)
Duration of treatment / exposure:
once (unrinsed)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
2
Details on study design:
A single instillation of 0.1 ml. by volume (35 mg.) of UDL 812 was made into the left eye of two healthy young rhesus monkeys. Twenty-four hours
prior to instillation, fluorescein examination confimed the absence of corneal damage in all eyes. The untreated eye served as a control. Treated eyes were held closed for one second postinstilletion and were graded and scored according to the system of J. K. Draize at 24, 48, and 72 hours and seven days. At each observation interval, treated eyes were examined with 2.0% sodim fluorescein stain for evidence of corneal damage.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
4
Irritant / corrosive response data:
Signs of eye irritation were slight, consisting of corneal dullness and slight conjunctival redness at 24 hours. All signs of eye irritation had subsided completely by 48 hours. Fluorescein stains were positive for corneal damage in both eyes at 24.hours.
Interpretation of results:
GHS criteria not met
Conclusions:
UDL 812 would be considered slightly irritating to the monkey eye under the conditions of this test. Signs of eye irritation consisted of corneal dullness and slight conjunctival redness in both eyes at 24 hours.
Executive summary:

UDL 812 was evaluated for eye irritation potential in monkeys by instillation of 0.1 ml. by volume (35 mg.) into the left eye of two rhesus monkeys.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
experimental phase: Jul. 20-28, 1988; report dated: Sep. 9, 1988
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
The eye irritating effects observed in this study may have been caused by an excess of caustic soda during the manufacturing process, which was not completely removed during subsequent washing processes and led to the extreme pH of 11.6.
Reason / purpose for cross-reference:
assessment report
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
not specified
GLP compliance:
yes
Specific details on test material used for the study:
Test Substance/ Trade Name/Identity: Wessalith P (A Zeolite)
Physical Appearance: White powder
Content/Purity: No known impurities
Solubility: Insoluble in water
pH-Value: Approx. 11.6
Storage: The test substance was kept at room temperature.
Stability: According to information from the sponsor, the test substance was stable throughout the experimental period.
Species:
rabbit
Strain:
other: White Russian (albino)
Details on test animals or tissues and environmental conditions:
Origin/Breeder: ASTA Pharma AG, 4800 Bielefeld; Germany
Age of the Animals at Treatment: 6-7 months
Body Weight of the Animals at Treatment : 2.4 - 2.77 kg
Caging: Stainless steel cages with grating floor, type ASTA, size: 48.5x40x36.5 cm (LxBxH)
Number of Animals per Cage: 1
Diet: Approx. Standard Diet ssniff K, "Special diet for rabbits"
Water: Water was provided ad libitum in drinking water quality
Room Temperature: 22 +/-2 °C
Relative Humidity: 55 +/-15 %
Room Lighting: 6 a.m. - 6 p.m. artificial lighting; 6 p.m. - 6 a.m. natural light-dark-rhythm

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
once (unrinsed)
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
0.1 gram of the test substance was applied into the conjunctival sac of the left eye. Then both lids were briefly closed by gentle finger pressure. The other eye of each animal was not treated and acted as control. The treated eye was not rinsed.
The treated eye was examined using a Cliptrix pencil light. Signs of irritation on the cornea, iris, and conjunctiva were assessed quantitatively and qualitatively using the Draize scale.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 4, 7, 8 d
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 4, 7, 8 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 4, 7, 8 d
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 4, 7 d
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 d
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 8 d
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 4, 7, 8 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 4 d
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 7, 8 d
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 4, 7, 8 d
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 4, 7, 8 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 4 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 4, 7, 8 d
Score:
0
Max. score:
4
Irritant / corrosive response data:
The single application of 0.1 gram Wessalith P into one conjunctival sac each of three rabbits caused only slight changes
In all animals, 24 hours after application of the test substance, the cornea showed slight diffuse opacity (rating 1) over the entire surface which had only completely subsided on the eighth day after treatment.
The iris showed slight hyperemia in one animal after 24 and 48 hours (rating 1).
The conjunctiva reacted in all animals immediately after application with diffuse, flesh-colored reddening (rating 3) and swelling with partial swelling or everted (2 animals) or half-closed (1 animal) lids (rating 2 and 3). These findings completely subsided at the latest on the 6th day of observation.
Immediately after the treatment, hypersecretion occurred, which moistened considerable areas around the eye.

The irritation index was 25. According to this, Wessalith P has slightly irritating properties on the rabbit's eye.


Other effects:
There were no systemic toxic effects after conjunctival application of the test substance. The general condition of the animals was undisturbed.
Hair loss was observed in one animal's eyelids.

The eye irritating effects observed in this study may have been caused by an excess of caustic soda during the manufacturing process, which was not completely removed during subsequent washing processes and led to the extreme pH of 11.6.

Interpretation of results:
study cannot be used for classification
Remarks:
The eye irritating effects observed in this study may have been caused by an excess of caustic soda during the manufacturing process, which was not completely removed during subsequent washing processes and led to the extreme pH of 11.6.
Conclusions:
The irritation index was 25. According to this, Wessalith P would have slightly irritating properties on the rabbit's eye. But an assessement of the study raised the question whether these results were not caused by an excess of caustic soda during the manufacturing process, which was not completely removed during subsequent washing processes.
Executive summary:

The purpose of the study was to test Wessalith P for irritating properties to the eyes.The study was carried out by introducing the test substance once into the conjunctival sac of one eye. In addition, attention was paid to the occurrence of systemic toxic effects.


It cannot be used for classification, because the eye irritating effects observed in this study may have been caused by an excess of caustic soda during the manufacturing process, which was not completely removed during subsequent washing processes and led to the extreme pH of 11.6.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substances Act (FHSA)
Version / remarks:
Title 16; Part 1500.42
Deviations:
not specified
Principles of method if other than guideline:
6 animals, one eye treated per animal, the other served as control, one dose level, single administration without rinsing, 7-day post observation, evaluation according to Draize
GLP compliance:
not specified
Specific details on test material used for the study:
Zeolite Type 13X (X Zeolite)
received on March 14, 1988 from Union Carbide Corporation, Whistler, Alabama
fine white powder
no identification number or CAS number available
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
For the tests, the animals were maintained on appropriate commercial diet and municipal water. Both were available ad libitum except during periods of manipulation.
Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
60 mg (= 0.1 ml)
Duration of treatment / exposure:
once
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
Male or female New Zealand White rabbits were dosed with a volume of 0.1 ml of solids. The dose was instilled into the lower conjunctival sac of one eye per animal. The eyelids were held together for one second. Six eyes were dosed per test volume. The eyes were scored at one hour, approximately 4 hours, one day, 2 days, 3 days and 7 days after dosing. Fluorescein (2%) staining was used to determine corneal injury before dosing and at readings after one day.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1, 4 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1, 4 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1, 4 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 4 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1, 4 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1, 4 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1, 4 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1, 4 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1, 4 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1, 4 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
7 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1, 4 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
7 d
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1, 4 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 1, 4 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: 1, 4 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #4
Time point:
7 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 1, 4 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
7 d
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 4 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
48 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
other: 1, 4 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #5
Time point:
other: 1, 4 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #5
Time point:
48 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #5
Time point:
7 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 1, 4 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
7 d
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
other: 4 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
other: 1, 4 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
7 d
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #6
Time point:
other: 1, 4 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #6
Time point:
7 d
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 1, 4 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
48 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
7 d
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: 1 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
other: 4 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
7 d
Score:
0
Max. score:
4
Irritant / corrosive response data:
Minor diffuse corneal injury and iritis were apparent in 5 of 6 rabbits following administration of 60 mg (0.1 ml). Minor to moderate conjunctival irritation was observed in all 6 eyes. By one hour, substantial discharge was noted in all rabbits. After 24 hours, minor corneal effects and iritis Persisted in 4 eyes. Minor to moderate conjunctival irritation was present in all 6 eyes. Two eyes healed within 48 hours. One eye still had minor corneal injury and 4 had conjunctival effects. All eyes were healed after 72 hours. By FHSA definition, based on 24-hour findings, 4 eyes were positive for corneal injury, iritis and conjunctival irritation. Therefore, Zeolite 13X was an FHSA irritant.

After instillation of 10 mg of Zeolite 13X, no eyes developed corneal opacity or iritis. Minor transient conjunctival irritation appeared in all 6 eyes. There was no irritation apparent by 24 hours. The results in the table above refer all to an installation of 60 mg.
Interpretation of results:
GHS criteria not met
Conclusions:
Four eyes positive at 24 hours; therefore, an ocular irritant by FHSA standards.
Executive summary:

The eye irritation potential of Zeolite Type 13X was assessed in six rabbits according to Federal Hazardous Substances Act (FHSA) standards.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In a human study a 1% suspension of a type A zeolite was tested on the back of 100 subjects with irritable skin, using a 24-hr patch-test procedure. No skin irritation was observed.

Justification for classification or non-classification

As neither the studies in skin irritation nor the reliable ones in eye irritation showed any significant effects according to tables 3.2.2. and 3.3.2 of the GHS (2019), there is no need for classification.