Registration Dossier
Registration Dossier
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EC number: 241-379-4 | CAS number: 17354-14-2
Endpoint summary
Administrative data
Description of key information
The test material was not irritating in vivo on rabbit skin as well as mucous membranes of rabbit eyes.. 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:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Early study, no GLP, short report
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- pre-dates GLP regulation
- Species:
- rabbit
- Strain:
- other: white Wiener
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BASF
- Age at study initiation: no data
- Weight at study initiation: 2,3 kg (mean)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum - Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 - 2 g/ animal
- Concentration (suspesion): 50 % - Duration of treatment / exposure:
- 20 h
- Observation period:
- 8 days
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: 6,25 cm²
- Type of wrap if used: semi-occlusve
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no - Irritation parameter:
- other: No numbers were given
- Remarks on result:
- other: In 3 of 4 animals very slight to slight reddening was observed
- Irritant / corrosive response data:
- In 3 of 4 animals very slight to slight, transient reddening was observed 24 h after treatment
- Other effects:
- Blue discoloration by the substance
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material not irritant after semi-occlusive treatment of rabbit skin for 20 hours.
- Executive summary:
The skin irritation hazard was tested in rabbits by semi-occlusive application of the test material for 20 hours. Animals were treated with a 50% aqueous paste. Observations werer made after 1, 5 oand 15 minutes of contact to the skin. Afterwards animals were treated for 20 hours.
After application for short periods the skin was without any finding. Application for 20 hours caused very slight to slight reddening of the treated areas in 3 of 4 rabbits. Additionally the skin was blue discolored by the test material.
Reference
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:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Early study, no GLP, short report
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Remarks:
- pre-dates GLP regulation
- Species:
- rabbit
- Strain:
- other: White Wiener
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: BASF
- Weight at study initiation: ca. 2,3 kg ( mean)
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum): ad libitum - Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- ca 50 mg
50% paste - Duration of treatment / exposure:
- not limitd (no washing)
- Observation period (in vivo):
- 8 days.
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
no - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: verbal report, no numbers given
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: all
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- other: verbal report, no numbers given
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 and 24 h
- Reversibility:
- fully reversible within: 8 days
- Remarks on result:
- other: slight reddening was reported, no number given
- Irritant / corrosive response data:
- Slight reddening of the conjunctivae was observed at 1 and 24 Hours after treatment.
- Other effects:
- no other effects occurred.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was not irritant or corrosive on the eyes of two rabbits.
- Executive summary:
Application of 50 mg/ animal on one eye of each rabbit caused only slight reddening of the conjunctivae after 1 and 24 hours. No systemic effects occurred. The material was not irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The skin irritation hazard was tested in rabbits by semi-occlusive application of the test material for 20 hours. Animals were treated with a 50% aqueous paste. Observations werer made after 1, 5 oand 15 minutes of contact to the skin. Afterwards animals were treated for 20 hours.
After application for short periods the skin was without any finding. Application for 20 hours caused very slight to slight reddening of the treated areas in 3 of 4 rabbits. Additionally the skin was blue discolored by the test material.
Application of 50 mg/ animal on one eye each of several rabbits caused only slight reddening of the conjunctivae after 1 and 24 hours. No systemic effects occurred. The material was not irritant.
Justification for selection of skin irritation / corrosion endpoint:
only available study
Justification for selection of eye irritation endpoint:
only available study
Justification for classification or non-classification
not classified;
Skin:
After application for short periods the skin was without any finding. Application for 20 hours caused very slight to slight reddening of the treated areas in 3 of 4 rabbit
Eye:
Application of 50 mg/ animal on one eye each of several rabbits caused only slight reddening of the conjunctivae after 1 and 24 hours. No systemic effects occurred. The material was not irritant.
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