Registration Dossier
Registration Dossier
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EC number: 242-358-2 | CAS number: 18479-49-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- non-GLP, lack of test article purity information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted May 12th, 1981
- GLP compliance:
- no
Test material
- Reference substance name:
- 3,7-dimethyloct-1-en-3-ol
- EC Number:
- 242-358-2
- EC Name:
- 3,7-dimethyloct-1-en-3-ol
- Cas Number:
- 18479-49-7
- Molecular formula:
- C10H20O
- IUPAC Name:
- 3,7-dimethyloct-1-en-3-ol
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- Animals were housed in fully air-conditioned rooms.
Temperature: RANGE OF 20 - 24 DEGREES CELSIUS
Relative humidity: 30 - 70%
Day/night rhythm: 12h/12h
Diet: 250 ml tap water per animal per day, 130g per animal of Kliba 341 4mm Firma Klingentalmuehle AG CH-4303 Kaiseraugst, Switzerland
Acclimatization period: at least 8 days before the beginning of the study, same housing conditions as during the study.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0,5 ml of undiluted test substance to the test patch (2.5 cm x 2.5 cm)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 (1 male, 2 females)
- Details on study design:
- Application site: upper third of the back or flanks
Readings: 30-60 minutes after removal of the test patches and 24h, 48h, 72h after the beginning of application.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
Any other information on results incl. tables
Evalutation of Erythema (R) and Edema (ED):
0 = None
1 = Very slight
2 = Well-defined
3 = Moderate to severe
4 = Severe to very severe
CALCULATION OF THE MEAN ACCORDING TO 83/467/EEC CRITERIA OF JULY 29TH, 1983
(FOR CALCULATION OF THE MEANS OF ERYTHEMA AND EDEMA ONLY READINGS OF 24,48 AND 72 HOURS ARE USED)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Very slight erythema (the Draize score = 1) and no edema were observed in two rabbits at 4 and 24 hours. For calculation of a mean of erythema and edema score only readings at 24, 48 and 72 hours after patch removal were used. The primary irritation index was calculated to be 0.2, therefore the test article is non-irritant to the rabbit skin. The mean scores per animal were 0.3, 0.0 and 0.3, therefore, the classification according to GHS criteria is also not a skin irritant (no classification).
- Executive summary:
The study performed in compliance with OECD 404 (version adopted in 1981) but not under GLP.
The dose (0.5 mL of the undiluted test article), application of the test substance (semi-occlusive) and the exposure period (4 h) were adequate. 3 rabbits were used (1 male, 2 females); intact skin.
Very slight erythema (the Draize score = 1) and no edema were observed in two rabbits at 4 and 24 hours. For calculation of a mean of erythema and edema score only readings at 24, 48 and 72 hours after patch removal were used. The primary irritation index was calculated to be 0.2, therefore the test article is non-irritant to the rabbit skin. The mean scores per animal were 0.3, 0.0 and 0.3, therefore, the classification according to GHS criteria is also not a skin irritant (no classification).
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