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Diss Factsheets

Administrative data

Description of key information

Skin: The test matarial  was not irritating to the rabbits' skin under the test conditions chosen.
Eyes: The test matarial  was not irritating to the rabbits' eyes under the test conditions chosen.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-01-04 and 1991-08-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP study, according to OECD Guideline 404 and Directive 84/449 EEC, B.4.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1984
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstraße 4, CH-4414 Füllinsdorf
- Age at study initiation: males: 14 weeks, females: 15 weeks
- Weight at study initiation: males: 2.9 kg, female 3.1 kg
- Housing: individually in stainless steel cages (size: 35.5 x 55.5 x 45 cm) equipped with an automatic cleaning and drinking system
- Diet: Pelleted standard Kliba 341, Batch 61/91 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Water Community tap water from Itingen, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g


Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
2 males
1 female
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap: It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: the skin was flushed with lukewarm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to the OECD scoring system
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 h/48 h/ 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 h/ 48 h / 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 h/48 h/ 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No acute clinical symptoms were observed in the animals during the test and observation period, and no mortality occurred. In the area of application a red staining of the treated skin by pigment or coloring of the test article was observed. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin. The body weight gain of all rabbits was similar.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non-GLP study, but according to OECD guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1984
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: 1 male, 2 females
- Weight at study initiation: male : 3.0 kg, females: 2.7 - 2.9 kg
- Housing: Individually in stainless steel cages (35.5 x 55.5 x 45 cm)
- Diet: Pelleted standard Kliba 341, Batch 62/91 rabbit maintenance diet ("Kliba", Klingentalmühle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Community tap water from Itingen, ad libitum
- Acclimation period: four days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40 -70
- Air changes (per hr): 10 -15
- Photoperiod (hrs dark / hrs light): 12/12 (music during the light period

Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied : 0.1 g


Duration of treatment / exposure:
The eyelids were held together for about one second. The test substance was not washed out.
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
1 male
2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: according to the OECD score system

TOOL USED TO ASSESS SCORE: hand-slit lamp 30 SL/M (C. Zeiss AG, Zuerich /Switzerland) and a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel /Switzerland)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Remarks on result:
other: not rinsed
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: not rinsed
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24 h/48 h/72 h
Score:
0
Max. score:
4
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 h/48 h/ 72 h
Score:
0
Max. score:
2
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
2
Remarks on result:
other: not rinsed
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
2
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 h/ 48 h/ 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: not rinsed
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0
Max. score:
4
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 h/ 48 h/ 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: not rinsed
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 h/ 48 h/ 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: not rinsed

No necropsy was performed in the animals euthanized at termination of observation. No acute clinical symptoms were observed in the animals during the test and observation period, and no mortality occured. The body weight gain of all rabbits was similar.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute Dermal Irritation

Key study

A skin irritation study in three New Zealand White rabbits (2 males, 1 female) was performed according to OECD guideline 404 and EU Method B.4. Therefore, 0.5 g of the test substance (60% act. ingr.) was applied to approx. 6 square cm of the intact skin of the clipped area and covered in a semi-occlusive manner for 4 hours. The skin reaction was assessed at 1, 24, 48 and 72 hours after the removal of the test substance. Local signs (mean values from 24, 48, 72 hours) consisted of grade 0.0 erythema and grade 0.0 edema. No acute clinical symptoms were observed in the animals during the test and observation period, and no mortality occurred. In the area of application a red staining of the treated skin by pigment or coloring of the test article was observed.

Supporting study

An acute dermal irritation study was performed in accordance to OECD guideline No. 404 and Method B4 in Commission Directive 92/69/EEC to determine the irritancy potential of the test material (49% act. ingr.) to the skin of three New Zealand White rabbits (2 females, 1 male). The rabbits were clipped free of fur from the dorsal flank area using veterinary clippers 24 hours before treatment. On the day of the test, a quantity of 0.5g of the test material, moistened with 0.5 mL of distilled water, was introduced under a 2.5 cm x 2.5 cm cottongauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period. Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits. Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale from Draize. Pink staining of the treatment site was noted in one animal at the 1, 24, 48 and 72-hour observations. Very slight erythema was noted at all treatment sites at the 1-hour observation and two treatment sites at the 24, 48 and 72-hour observations. Desquamation was noted at two treatment sites at the 7-day observation. An isolated incident of very slight oedema was noted at one treatment site at the 24-hour observation.

Conclusion

The mean values of the recordings 24 to 72 hours after treatment for both erythema and edema were in the range of 0 to 1 for all individual animals. Both the key and supporting study indicated that the test material was not irritating to the rabbits' skin.

Acute Eye Irritation

Key study

An eye irritation study in three New Zealand rabbits (1 male, 2 females) was performed according to OECD guideline 405 and EU Method B.5. 0.1 g of the test substance (60% act. integr.) was placed in the left eye of each animal and the lids were gently held together for about one second. The eyes of each animal were exmamined for ocula irritation 1, 24, 48, 72 hours, 7, 14 and 21 days after administration.

No necropsy was performed in the animals euthanized at termination of observation. No acute clinical symptoms were observed in the animals during the test and observation period, and no mortality occured. The body weight gain of all rabbits was similar. The mean scores (over time points 24 h, 48 h, 72 h) for animal 1 were determined to be 0.0 for cornea, 0.0 for iris, 1.0 for conjunctivae redness and 0.0 for chemosis. For animal 2, the mean scores were 0.33 for cornea, 0.0 for iris, 1.0 for conjunctiva redness and 0.33 for chemosis. For animal 3, the mean scores were 0.0 for cornea, 0.0 for iris, 1.0 for conjunctiva redness and 1.0 for chemosis. The observed effects were fully reversible within the 21 -day observation period.

Supporting study

An acute eye irritation study was performed in accordance to OECD guideline No. 405 and Method B5 in Commission Directive 92/69/EECto determine the irritancy potential of the test material (49% act. integr.) to the eyes of three New Zealnd White rabbits (2 females, 1 male). A volume of 0.1 mL of the test material, which was found to weigh approximately 98 mg was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after application, to prevent loss of the test material, and then released. The left eye remained untreated and was used for control purposes.In order to minimise pain on instillation of the test material, one drop of local anaesthetic ("Ophthaine", 0.5% proxymetacaine hydrochloride, E.R. Squibb & Sons Limited, Hounslow, Middlesex, U.K.) was instilled into both eyes of these animals 1 - 2 minutes before treatment. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment in accordance to the OECD scoring system. Examination of the eye was facilitated by use of the light source from a standard ophthalmoscope. Additional observations were made on days seven, fourteen and twenty-one to assess the reversibility of the ocular effects. Residual test material was noted in all treated eyes throughout the study period. The mean scores (over time points 24 h, 48 h, 72 h) for animal 1 were determined to be 0 for cornea, 0 - 1.3 for iris, 0.7 - 1.7 for conjunctivae redness and 1.3 for chemosis. Dark pink/purple-coloured staining prevented accurate evaluation of iridial inflammation in the treated eye of animal 2 at the 24 and 48 -hour observations. For animal 2, the mean scores were 0 for cornea, 0 for iris, 1 for conjunctiva redness and 0.7 for chemosis. For animal 3, the mean scores were 1.0 for cornea, 0.3 for iris, 1.7 for conjunctiva redness and 1.3 for chemosis. Likewise, vascularisation in animal 3 was observed at the 7 and 14 -day obervations. The observed irritation paramters were fully reversible within the observation period.

Conclusion

On the basis of the key and supporting study, the test material is considered to be non-irritating to the rabbits' eye.


Justification for selection of skin irritation / corrosion endpoint:
OECD guideline study; test material with highest concentration of active ingredient

Justification for selection of eye irritation endpoint:
OECD guideline study; test material with highest concentration of active ingredient

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No 1272/2008, as amended for the seventh time in Regulation (EC) No 2015/1221.