Registration Dossier
Registration Dossier
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EC number: 236-852-7 | CAS number: 13515-40-7
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 erythema or edema were visible (score 0) in any of the 3 animals tested during the observation period (up to 72 hours after end of the 4 h exposure period). The treated skin sites showed a yellow discoloration.
The test material was subjected to an Acute Eye Irritation / Corrosion Test in the rabbit according to OECD TG 405. No iridial effects were noted during the study. Very slight corneal opacity was observed in one animal 48 and 72 hours after test substance application but not in the two other test animals at any timepoint. Conjunctival redness was observed in every animal one hour after application, and in two animals 24 hours after application, fully reversible by 48 h after application. Chemosis was observed in every animal only one hour after application but not at later time points.
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 04 OCT 1983 to 07 OCT 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study (OECD TG 404) GLP compliant
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute 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
- strain: Hoe: HIMK (SPFWiga)
- Source: Hoechst AG, in-house SPF-breeding
- Weight at study initiation: 2.6-2.9 kg
- Housing: individually
- Diet: Altromin 2123 for rabbit husbandry (Altromin, Lage/Lippe), ad libitum
- Water: deionised, chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 10
- 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 mL polyethylene glycol 400 - 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 an adhesive tape in contact with skin site
- Type of wrap: semiocclusive bandage
REMOVAL OF TEST SUBSTANCE
- 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
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- None of the animals showed any skin reaction. Erythema and edema scores were 0 at all time points of observation.
- Other effects:
- Yellow discolouration of treated skin sites.
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test item is not irritating to skin under the test conditions.
- Executive summary:
The test material was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404. No erythema or edema were visible (score 0) in any of the 3 animals tested during the observation period (up to 72 hours after end of the 4 h exposure period). The treated skin sites showed a yellow discoloration.
- 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 04 OCT 1983 to 07 OCT 1983.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 405) GLP compliant, observation time not extended to the time point of full reversibility of all effects
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- observation time only till 72 hours after start of exposure, but not until full reversibility of all effects
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Strain: Hoe: HIMK (SPFWiga)
- Source: Hoechst AG, in-hous conventional breeding
- Weight at study initiation: 2.7-3.3 kg
- Housing: individually
- Diet: Altromin 2123 diet for breeding rabbits (Altromin, Lage/Lippe), ad libitum
- Water: deionised, chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h - Vehicle:
- other: polyethylene glycol 400
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 mg pasted with 0.2 ml polyethylene glycol 400 - 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 (if done): 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, magnifying glass - Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: cornea opacity was only observed 48 and 72 hours after application, observation time ended at 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- 48 h after application.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- not applicable
- Irritant / corrosive response data:
- - no iridial effects occurred during the study
- chemosis scores for animal #1,2,3 after 1 h: (2,1,1). After 24, 48 and 72 h scores for all animals were 0.
- redness of the conjunctivae scores for animal #1,2,3 after 1 h: (2,1,1), after 24 h: (1,1,0). After 48 h and 72 h scores for all animals were 0.
- cornea opacity scores for animal #1,2,3 after 1 h and 24 h was 0 for all animals. After 48 h: (1,0,0) and after 72 h: (1,0,0)
- Heavy discharge was observed in every animal one hour after application. - Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test item did not induce iridial effects under the conditions of this test. Effects on conjunctivae redness and chemosis were sligth to moderate and fully reversible within 72 hours after start of the exposure. One animal showed very slight corneal opacity at 48 and 72 hours after start of the exposure, but not at earlier timepoints. As no corneal effects were observed in the two other animals it can reasonable be assumed that the slight effects seen in this animal would also be reversible within some days. Therefore it is concluded that the test item has not to be classified as an eye irritant according to the classification criteria of Regulation (EC) No 1272/2008.
- Executive summary:
The test material was subject to an Acute Eye Irritation / Corrosion Test in the rabbit according to OECD TG 405. No iridial effects were noted during the study. Very slight corneal opacity was observed in one animal 48 and 72 hours after test substance application but not in the two other test animals at any timepoint. Conjunctival redness was observed in every animal one hour after application, and in two animals 24 hours after application, fully reversible by 48 h after application. Chemosis was observed in every animal only one hour after application but not at later time points.
- 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
The test item was not irritant after dermal or ocular exposure in vivo.
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