Registration Dossier
Registration Dossier
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EC number: 916-807-4 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of 1,2,3,4,5,6,7,8-octahydro-5,5-dimethylnaphthalene-2-carbaldehyde and 1,2,3,4,5,6,7,8-octahydro-8,8-dimethyl-2-naphthaldehyde
- EC Number:
- 916-807-4
- Molecular formula:
- C13H20O
- IUPAC Name:
- Reaction mass of 1,2,3,4,5,6,7,8-octahydro-5,5-dimethylnaphthalene-2-carbaldehyde and 1,2,3,4,5,6,7,8-octahydro-8,8-dimethyl-2-naphthaldehyde
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Description: Clear, transparent liquid
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ENKI—Konijnenfarm, Someren, the Netherlands
- Weight at study initiation: 2500-3500 g
- Housing: individually in suspended, galvanized cages, fitted with wire-mesh floor and front
- Diet: Standard laboratory rabbit diet, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3
- Humidity (%): 40-70
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 21 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: One day prior to the start of the experiment, the hair was removed from the back and flanks of the animals using electric clippers in a way as to avoid abrasions
- Type of wrap if used: Surgical patch measuring 1 inch x I inch. The patches were fixed to the application site by means of adhesive tape and the entire trunk of the rabbits was wrapped with an impervious material.
REMOVAL OF TEST SUBSTANCE
- Washing: no
OBSERVATION TIME POINTS
- Immediately after removal of the test substance and 24, 48, and 72 hours later
SCORING SYSTEM:
- By the method of Draize (J. Pharmacol. exptle Therape 82 (1944) 377—390).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 3 weeks
- Irritation parameter:
- erythema score
- Basis:
- animal: #2, #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 weeks
- Irritation parameter:
- erythema score
- Basis:
- animal: #3, #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 weeks
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 weeks
- Irritation parameter:
- edema score
- Basis:
- animal: #2, #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 weeks
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 weeks
- Irritant / corrosive response data:
- After three weeks only very slight erythema and slight scaliness were still observed in one rabbit.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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