Registration Dossier
Registration Dossier
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EC number: 225-822-9 | CAS number: 5102-83-0
Endpoint summary
Administrative data
Description of key information
The test material was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404. No skin reactions occured except a very slight erythema in 1/3 animals one hour after the end of exposure. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008
The test material was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405. No corneal effects were observed. Iridial responses were observed 24 h after application, fully reversible by 48 h after application. Conjunctival redness and Chemosis were observed in 3/3 animals up to 48 hours after application, fully reversible by 72 hours after application. As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 10 OCT 1989 to 13 OCT 1989.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 404).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.4-3.5 kg
- Housing: individually
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage/Lippe), ad libitum, plus hay ca. 15 g per day
- Water: deionised, chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 h / 12 h - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 500 mg pasted with 0.4 ml 0.9% NaCl solution - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5x2.5 cm² cellulose patch of a surgical plaster (Beiersdorf)
- Type of wrap if used: semiocclusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm tap water
- Time after start of exposure: 4 h
SCORING SYSTEM: according to OECD TG 404 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h.
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h.
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- 1/3 animals showed erythema score 1 one hour after exposure. No other skin reactions were observed at any other time points.
- Other effects:
- Large yellow discolouration of 3/3 skin sites, which was no longer observable on day two.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP regulation
- Conclusions:
- According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to skin under these test conditions. The test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
- Executive summary:
The test material was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404. No skin reactions occured except a very slight erythema in 1/3 animals one hour after the end of exposure. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 24 OCT 1989 to 27 OCT 1989.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 405).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.9-3.7 kg
- Housing: individually
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage/Lippe), ad libitum, plus hay ca. 15 g per day
- Water: deionised, chlorinated water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 h / 12 h - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 mg - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: with ca. 37 °C warm physiol. saline
- Time after start of exposure: 24 h
SCORING SYSTEM: according to OECD TG 405
TOOL USED TO ASSESS SCORE: fluorescein, UV light - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h.
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h.
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: #2, #3
- Time point:
- other: 24, 48, 72 h.
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- 48 h after application.
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h.
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- 72 h after application.
- Remarks on result:
- other: redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h.
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- 72 h after application.
- Remarks on result:
- other: redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h.
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- 72 h after application.
- Remarks on result:
- other: redness
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48, 72 h.
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 48 h after application.
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48, 72 h.
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 72 h after application.
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48, 72 h.
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- 72 h after application.
- Irritant / corrosive response data:
- No corneal opacity was observed during the study. Iris score 1 was observed in 2/3 animals 24 h after application. No other iridial responses were observed. Conjunctival redness was observed in every animal one, 24 and 48 h after application (max. score 3). Chemosis was observed in every animal one and 24 h after application and in 2/3 animals 48 h after aplication. No effects were noted 72 h after application.
- Other effects:
- Transparent discharge, yellow coloured from test substance, was observed in every animal one hour after application and in one animal 24 h after application.
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: other: CLP regulation
- Conclusions:
- According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions. Test material Permanent-Gelb P-GRL neu contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
- Executive summary:
The test material was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405. No corneal effects were observed. Iridial responses were observed 24 h after application, fully reversible by 48 h after application. Conjunctival redness and Chemosis were observed in 3/3 animals up to 48 hours after application, fully reversible by 72 hours after application. As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No classification
The test item did not cause irritant effects on skin and eyes in two in vivo studies in rabbits.
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