Registration Dossier
Registration Dossier
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EC number: 290-823-3 | CAS number: 90268-23-8
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 and did not cause any signs of skin irritation besides very slight erythema in 1/3 animals one hour after exposure.
The test material was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405. Slight eye reactions were noted only one hour after application. 24, 48 and 72 h after application no effects were noted. 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 19 JUL 1988 to 22 JUL 1988.
- 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: 2.0-2.6 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:
- other: polyethylene glycol 400
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 500 mg pasted with 1.0 ml polyethylene glycol 400.
VEHICLE
- Lot/batch no.: Ch-B 2322, Riedel-de Haen - 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 water
- Time after start of exposure: 4h
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:
- No edema was observed during the study. One hour after exposure 1/3 animals showed erythema score 1. 24 h after exposure no other effects were observed. 48 h and 72 h after exposure no effects were observed.
- Other effects:
- One hour and 24 h after exposure every animal showed yellow discolouration of skin sites, which was no longer observable 48 h after exposure.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP regulation
- Conclusions:
- The test material is not irritating to skin under these test conditions.
- Executive summary:
The test material was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404 and did not cause any signs of skin irritation besides very slight erythema in 1/3 animals one hour after exposure. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.
- 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
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 02 AUG 1988 to 05 AUG 1988.
- 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: 2.0-2.7 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:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: redness
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No corneal effects were noted during the study. Iris score 1 and iridial redness were observed in 2/3 animals one hour after application. Chemosis score 1 in 2/3 animals and conjunctival redness of score 2 in 3/3 animals were observed one hour after application. 24, 48 and 72 h after application no effects were noted.
- Other effects:
- Discharge of yellow colour from test substance was observed in 2/3 animals one hour after application.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP regulation
- Conclusions:
- The test material is not irritating to eyes under these test conditions.
- Executive summary:
The test material was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405. Slight eye reactions were noted only one hour after application. 24, 48 and 72 h after application no effects were noted. The test material is not irritating to eyes and has not to be classified for eye irritation.
- 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
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
PY 126 was not irritating to skin and eyes in vivo.
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