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Administrative data

Description of key information

Bayhibit AM was tested as a ca. 50 % solution water in vivo and as a water-free substance (Bayhibit AM wasserfrei) in vitro.
The water-free substance (Bayhibit AM wasserfrei) was found to be not irritating or corrosive in vitro experiments with 3D-skin.
The water-free substance (Bayhibit AM wasserfrei) was found to be irritating in the Human Corneal Epithelial Model (HCE) but slightly irritating in the Hen's Egg Chorioallantoic Membrane (HET-CAM) test.
Skin and eye irritation tests with the 50% aqueous gave negative results.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study
Qualifier:
according to guideline
Guideline:
other: OECD TG 431
Qualifier:
according to guideline
Guideline:
other: EU Method B.40 (Skin Corrosion)
Principles of method if other than guideline:
The experiment was carried out on a reconstructed human epidermis EST-1000 (CeIiSystems, St. Katharinen, Germany)
GLP compliance:
yes
Species:
other: not applicable - in-vitro 3D skin corrosion test
Strain:
other: not applicable - in-vitro 3D skin corrosion test
Type of coverage:
other: not applicable - in-vitro 3D skin corrosion test
Preparation of test site:
other: not applicable - in-vitro 3D skin corrosion test
Vehicle:
other: not applicable - in-vitro 3D skin corrosion test
Controls:
other: not applicable - in-vitro 3D skin corrosion test
Duration of treatment / exposure:
After an exposure period of 3 or 60 minutes, followed by a post-treatment incubation period of about 3 hours, the cell viability was measured
Observation period:
not applicable - in-vitro 3D skin corrosion test
Number of animals:
not applicable - in-vitro 3D skin corrosion test
Irritation / corrosion parameter:
other: other: cell viability
Value:
109.19
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 3 minutes. Max. score: 100.0. Reversibility: other: not applicable - in-vitro 3D skin corrosion test. Remarks: non corrosive - scores in [%] viability. (migrated information)
Irritation / corrosion parameter:
other: other: cell viability
Value:
19.64
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 60 minutes. Max. score: 100.0. Reversibility: other: not applicable - in-vitro 3D skin corrosion test. Remarks: non corrosive - scores in [%] viability. (migrated information)

Compound                                   [%] Cell viability 3 min       [%] Cell viability 60 min      Classification*

Bayhibit AM wasserfrei                            109.19                                      19.64               Non-corrosive                   

Negative control                                          100                                          100                 Negative control

*: Classification was done in accordance with the existing guideline and

internationally accepted protocols, i.e. evaluation of LD50 values after 3 min. and/or less than 15% viability after a 60 min. incubation period.

Executive summary:

This study for predicting non-specific, corrosive potentials of compounds by using reconstructed human skin (RHS) was performed in 2011. The experiment was carried out on a reconstructed human epidermis EST-1000 (CellSystems, St. Katharinen, Germany) for detection of topically applied skin corrosives with the test item Bayhibit AM wasserfrei.

Corrosive skin effects of substances are defined as irreversible damage of skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test substance for up to four hours. In vivo corrosive reactions are typified by ulcers, bleeding, and bloody scabs.

A 100% concentration was tested on the skin/epidermal equivalents in triplets. For the determination of time related cytotoxic effects the incubation periods were 3 min. and 60 min., respectively. By this the study, was conducted in accordance with the OECD 431 guideline as well as with an EC guideline (amending Council Directive 67/548/EEC, B.40 Skin corrosion) using the test item concentrations and incubation periods recommended there. These tests are also related to the revised OECD 404 guideline "Acute Dermal Irritation/Corrosion".

To check the reliability of this test procedure a blinded positive/negative control study is conducted at regular intervals in the lab. This reliability check is always performed by two technicians, two laboratories in parallel using the same batches of the control test items.

The test item was applied at a 100% concentration, i.e. 25mg per insert.

(plus 50µl 0.9% NaCl to moisten and ensure good contact with the skin)

The MTT (Methylthiazoletetrazolium) method has determined the following values of viability after 3 min. or after 60 min. of incubation: 109% and 20% (rounded), respectively. Thus, the results show that no corrosive property of the test item was determined by the assay used.

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study
Qualifier:
according to guideline
Guideline:
other: EU Test Method B.46
Principles of method if other than guideline:
The experiment was carried out on a reconstructed human epidermis EST-1000 (CeIiSystems, St. Katharinen, Germany)
GLP compliance:
yes
Species:
other: not applicable - in-vitro 3D skin irritation test
Strain:
other: not applicable - in-vitro 3D skin irritation test
Type of coverage:
other: not applicable - in-vitro 3D skin irritation test
Preparation of test site:
other: not applicable - in-vitro 3D skin irritation test
Vehicle:
other: not applicable - in-vitro 3D skin irritation test
Controls:
other: not applicable - in-vitro 3D skin irritation test
Duration of treatment / exposure:
After an exposure period of 20 minutes, followed by a 42 hours post-treatment incubation period, the cell viability was measured
Observation period:
not applicable - in-vitro 3D skin irritation test
Number of animals:
not applicable - in-vitro 3D skin irritation test
Irritation / corrosion parameter:
other: other: cell viability
Value:
113.13
Remarks on result:
other:
Remarks:
Basis: mean. Time point: ca. 42 hours. Max. score: 100.0. Reversibility: other: not applicable - in-vitro 3D skin irritation test. Remarks: non irritant - scores in [%] viability. (migrated information)

Compound                             Cell viability [%]        Classification*

Katalysator WAZ 5596 -B       113.13                  Non Irritant (NI)

Positive control                         6.62                      Irritant (I)

Negative control                     100.00                    Non irritant (NI)

*: Classification was done in accordance with EU Test Method B.46.

In vitro result                      In vivo prediction

mean tissue viability<50        Irritant (I)

mean tissue viability > 50       Non-irritant (NI)

(I): Irritant , R38 = Skin irritation category 2, H315

(NI): Non – irritant = no skin irritation category

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

This study which allows the hazard identification of irritant substances in accordance with UN GHS category 2, was performed in 2011. The experiment was carried out according to EU Test Method B.46 using commercially available reconstructed human epidermis (RHS) model EST-1000 (CellSystems, St.Katharinen, Germany).

Undiluted Bayhibit AM wasserfrei was applied topically to the RHS model, i.e. 30 mg per insert (plus 30 µl 0.9% NaCl to moisten and ensure good contact with the skin; three replicates).

After an exposure period of 20 minutes, followed by a 42 hours post-treatment incubation period, the cell viability was measured to be 113% (rounded) in the MTT (Methylthiazoletetrazolium) conversion assay.

The results of the concurrent negative control (NC, 0.9% NaCl) and positive control (PC, 5% SDS) demonstrated the viability (NC) and sensitivity (PC) of the test model.

Thus, the results show that Bayhibit AM wasserfrei is considered to have no skin irritation category.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Not indicated
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
The study was originally done according to EG-guideline 83/467
Deviations:
yes
Remarks:
, see below
Qualifier:
equivalent or similar to guideline
Guideline:
other: EG-guideline 83/467
Principles of method if other than guideline:
1- 7 days observations instead of 14 days.
2- Scoring evaluations for 7 days instead of 72 hours.
3- Exposure period of 24 hours instead of 4 hours.
4- Application of the substance- occlusive, on the inner part of the ear, instead of semi-occlusive on a shaved skin.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Weight at study initiation: 2.4 - 4.0 kg
- Diet: Standard lab diet, ad libitum
- Water: ad libitum



Type of coverage:
occlusive
Preparation of test site:
other: The test area was selected intentionally to be the hairless inner part of the ear.
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL of the undiluted test substance.
Duration of treatment / exposure:
24 hours exposure.
Observation period:
Period of observation-7 days. Grading of the skin reaction was done after the patch was removed (after 24 hours of exposure) and in the 2nd, 3rd, 6th and 7th day.
Number of animals:
2 rabbits.
Details on study design:
TEST SITE
- Area of exposure: The hairless inner side of the ear
- Type of wrap if used: Small cellulose tissues with the undiluted test substance was attached with plasters to the inner side of the rabbit's ear. For better support, a rolled piece of cellulose was attached to the ear.





Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score = 0 at any time point
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score = 0 at any time point
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable 0 - score = 0 at any time point
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score = 0 at any time point
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution
Irritant / corrosive response data:
No irritation/corossive effects were found - a score of 0 was given to each of the examined parameter.
Other effects:
No other effects.

No remarks.

Interpretation of results:
GHS criteria not met
Conclusions:
Non-irritant.
Executive summary:

A 50% aqueous solution of 2-phosphonobutane-1,2,4-tricarboxylic acid was tested for skin irritation effects. The substance was applied on the inner side of ear of two rabbits, for 24 hours. The test animals were observed for any physiological changes for 7 days. No dermal irritation or dermal corrosion was seen in any time point. 2-Phosphonobutane-1,2,4-tricarboxylic acid can be considered under the study conditions to be a non-irritant/corrosive substance. Although there are some differences between the way the (relatively old) study was conducted to the OECD 404 guideline, it seems that there is no need in repeating the study for animal welfare reasons, especially due to the fact that the test substance was defined in the study as non-irritant under stricter test conditions than the ones indicated by the OECD guideline.

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

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study
Principles of method if other than guideline:
In vitro study for assessing ocular irritation of compounds using a human epithelial corneal cell model. The model used is standardized and commercially available (SkinEthic™ Human Corneal Epithelial Model (HCE); SkinEthic, France).
GLP compliance:
yes
Species:
other: not applicable - human corneal epithelial model (HCE)
Strain:
other: not applicable - human corneal epithelial model (HCE)
Vehicle:
other: not applicable - human corneal epithelial model (HCE)
Controls:
other: not applicable - human corneal epithelial model (HCE)
Duration of treatment / exposure:
After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was measured
Observation period (in vivo):
not applicable - human corneal epithelial model (HCE)
Number of animals or in vitro replicates:
not applicable - human corneal epithelial model (HCE)
Irritation parameter:
other: cell viability
Run / experiment:
60 minutes followed by a 16 h post-treatment period
Value:
1.98
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: irritant - scores in [%] viability

A test substance is predicted to be an ocular irritant if the mean relative tissue viability (%) exposed to the test substance is<50%.

As can be seen from the information in the Table below the test substance

Bayhibit AM wasserfrei was detected as irritant to the cornea epithelium in this test model.

Compound              Cell viability [%] Evaluation

Bayhibit AM wasserfrei      1.98        irritant

Positive control               28.91      irritant

Negative control              100.00      non-irritant

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Executive summary:

This in vitro study for assessing ocular irritation of compounds using a human epithelial corneal cell model was performed in 2011. The model used is standardized and commercially available (SkinEthicTM Human Corneal Epithelial Model (HCE); SkinEthic, France).

Undiluted Bayhibit AM wasserfrei was applied topically to the HCE tissue, i.e. 30 mg per insert. (plus 30 µl PBS to moisten and ensure good contact with the skin; three replicates)

After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was 2% (rounded) as measured by a MTT conversion assay.

The results of the concurrent negative (NC, PBS) and positive control

(PC, 1H-1,2,4-Triazole-3-thiol) demonstrated the viability (NC) and sensitivity (PC) of the test model.

The results show that Bayhibit AM wasserfrei is predicted as ocular irritant under the conditions of this test method.

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study
Qualifier:
according to guideline
Guideline:
other: ICCVAM Test Method Evaluation Report: Appendix G: ICCVAM Recommended Protocol for Future Studies Using the Hen's Egg Test-Chorionallantoic Membrane (HET-CAM) Test method, November 2006
Principles of method if other than guideline:
The hen's egg test was modified as an alternative to the rabbit's eye irritation/corrosion test. The extra-embryonal blood vessel system of the incubated chicken egg is used to observe the acute toxicological effects of irritant/corrosive test substances. This test was performed by using the chorionallantoic membrane (HET-CAM, 8d incubation) of chicken eggs
GLP compliance:
yes
Species:
other: not applicable (in vitro study)
Strain:
other: not applicable (in vitro study)
Vehicle:
unchanged (no vehicle)
Controls:
other: not applicable (in vitro study)
Duration of treatment / exposure:
single treatment
Observation period (in vivo):
Effects are measured by the onset of haemorrhage, vessel lysis or coagulation during the first 300 seconds after application
Number of animals or in vitro replicates:
not applicable - in vitro study (4 eggs were used)
Irritation parameter:
other: Irritant score
Run / experiment:
IS = 5 x (301-sec H)/300 + 7 x (301- sec L)/300 + 9 x (301- sec C)/ 300
Value:
3
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: H= observed start in seconds of haemorrhage reactions L= observed start in seconds of vessel lysis, strong haemorrhage C= observed start in seconds of blood - coagulation, albumen - coagulation

                           HET-CAM Index

Negative Control NaCl 0.9% 0 Non irritant

Positive Control SDS 1% 11 Strong irritant

Bayhibit AM wasserfrei 3 Slight irritant

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Executive summary:

Hen`s egg tests are used to determine the potential irritant/corrosive property of a test compound using an in vitro alternative to the Draize methodology (OECD405).

Bayhibit AM wasserfrei was tested by observing possible adverse changes after application onto the chorioallantoic membrane (HET-CAM).

After the application of the test item blood vessels and albumen were examined and scored for the following irritant effects: vasodilation, slight haemorrhage; vessel lysis, strong haemorrhage; blood coagulation, albumen coagulation for a period of 300 seconds.

300 mg of the test item was applied per egg directly on the chorioallantoic membrane.

Bayhibit AM wasserfrei was identified as “slight irritant” to the chorioallantoic membrane (Irritation Score (IS) = 3) under the conditions of this assay.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A 50% aqueous solution of 2-phosphonobutane-1,2,4-tricarboxylic acid was used.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
, see below
Qualifier:
according to guideline
Guideline:
other: EG-guideline 83/467
Principles of method if other than guideline:
More than 72 hours of observation (7 days). No mean calculation of the scores was performed for grading.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Weight at study initiation: 2.4-4.0 kg
- Diet: Standard lab diet, ad libitum
- Water: ad libitum

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL of the undiluted test substance was applied into the conjunctival sac.
Duration of treatment / exposure:
Single application. No rinsing after application.
Observation period (in vivo):
7 days. Effects were examined just after exposure (1 hour), after 24 hours and in the 2nd, 3rd, 6th and 7th day after exposure.
Number of animals or in vitro replicates:
2 rabbits.
Details on study design:
No further details.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1, 24 hours, 2nd day
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 3rd, 6th, 7th day
Score:
0
Max. score:
4
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1, 24 hours, 2nd, 3rd, 6th, 7th day
Score:
0
Max. score:
2
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution
Irritation parameter:
other: Erythema score
Basis:
animal #1
Time point:
other: 1 hour
Score:
2
Max. score:
3
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution
Irritation parameter:
other: Erythema score
Basis:
animal #1
Time point:
other: 24 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution
Irritation parameter:
other: Erythema score
Basis:
animal #1
Time point:
other: 2nd, 3rd, 6th,7th day
Score:
0
Max. score:
3
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1, 24, hours, 2nd, 3rd day
Score:
1
Max. score:
4
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 6th, 7th day
Score:
0
Max. score:
4
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1, 24 hours, 2nd day
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 3rd, 6th, 7th day
Score:
0
Max. score:
4
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1, 24 hours, 2nd, 3rd, 6th, 7th day
Score:
0
Max. score:
2
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution
Irritation parameter:
other: Erythema score
Basis:
animal #2
Time point:
other: 1, 24 hours, 2nd, 3rd day
Score:
1
Max. score:
3
Reversibility:
fully reversible within: < = 6 days
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution
Irritation parameter:
other: Erythema score
Basis:
animal #2
Time point:
other: 6th, 7th day
Score:
0
Max. score:
3
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1, 24 hours, 2nd, 3rd day
Score:
1
Max. score:
4
Reversibility:
fully reversible within: < = 6 days
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 6th, 7th day
Score:
0
Max. score:
4
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.83
Max. score:
4
Reversibility:
not fully reversible within: 6 days
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution.
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: Composition of test material, percentage of components: 50% aqueous solution.
Irritant / corrosive response data:
Irritating reversible effects as redness and swelling of the eyes (the conjunctivae tissue) were observed. No corrosive response was observed.
The study concludes a moderate eye irritating effect following the highest score for each parameter for the two rabbits examined.
Other effects:
No other effects

No remarks.

Interpretation of results:
GHS criteria not met
Conclusions:
Under the test conditions, the test substance was considered as a moderate mucosa (eye) irritant, based on the highest and not on the mean of 24, 48, 72 hours.
Executive summary:

A 50% aqueous solution of 2-phosphono-butane-1,2,4-tricarboxylic acid was examined for eye irritation effects in rabbits. Results showed light short-termed opacity of the cornea and light redness and swelling of the conjunctivae in both examined animals. No other effects, e.g. corrosive effects were observed. The observed irritation effects were reversible during the time frame of the study. Following the highest score given to each one of the investigated parameters (see in table above), the conclusion was that under the test conditions the test substance has a moderately mucosa (eye) irritation effect. However, when the presented study results/scores are evaluated by a calculation of the mean scores and rated according to the current instructions by the Regulation (EC) No 1272/2008, the test substance should thereby be classified as non-irritant. Nevertheless, as the study was reasonably done and the conclusion from this study would be less strict under the current mentioned regulations, it is therefore recommended for animal welfare not to repeat the study.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Bayhibit AM was tested as a ca. 50 % solution water in vivo and as a water-free substance (Bayhibit AM wasserfrei) in vitro.

The water-free substance (Bayhibit AM wasserfrei) was found to be not irritating or corrosive to skin in vitro experiments with 3D-skin.

The water-free substance (Bayhibit AM wasserfrei) was found to be irritating to eye in the Human Corneal Epithelial Model (HCE) and slightly irritating to eye in the Hen's Egg Chorioallantoic Membrane (HET-CAM) test.

Skin and eye irritation tests with the 50% aqueous solution gave negative results.


Effects on eye irritation: irritating

Justification for classification or non-classification

Skin:

The water-free substance (Bayhibit AM wasserfrei) was found to be not irritating or corrosive in vitro experiments with 3D-skin.

Skin irritation tests with the 50% aqueous gave negative results.

Eye:

The water-free substance (Bayhibit AM wasserfrei) was found to be irritating in the Human Corneal Epithelial Model (HCE) and slightly irritating in the Hen's Egg Chorioallantoic Membrane (HET-CAM) test.

Eye irritation tests with the 50% aqueous gave negative results.

Overall, the water-free substance (Bayhibit AM wasserfrei) should be classified with Eye Irrit. 2 ( H319: Causes serious eye irritation) based on the in vitro data.