Registration Dossier
Registration Dossier
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EC number: 412-450-9 | CAS number: 131766-73-9 CLARYCET
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:
- other: Study conducting according to OECD method by a GLP accredited laboratory.
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 84/449/EEC, Annex V, Method B4 and OECD guideline for Toxicity Testing of Chemicals, No. 404.
- GLP compliance:
- yes
Test material
- Reference substance name:
- A mixture of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran; cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran
- EC Number:
- 412-450-9
- EC Name:
- A mixture of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran; cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran
- Cas Number:
- 131766-73-9
- Molecular formula:
- C11H20O3
- IUPAC Name:
- reaction mass of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- New Zealand White rabbits (weight range 3.4-4.1 kg).
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Clipping
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 minutes after patch removal and on days 2 to 9.
- Number of animals:
- 3
- Details on study design:
- A 4 hour semi-occlusive application of pure test material was made to clipped skin of 3 New Zealand White rabbits. The treatment site was washed at patch removal. Reactions were graded 30 minutes after patch removal and on days 2 to 9. Observations for signs of toxicity were also conducted.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days.
- Irritation parameter:
- erythema score
- Basis:
- other: maximum score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mena score 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- other: maximum score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Very slight to well-defined erythema was seen in 1 rabbit days 1-8 and very slight erythema was seen in 1 rabbit days 1-4, which persisted for a further two to six days before resolving by days 9 or 5. No reaction was seen in the third rabbit following the removal of the dressings.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance does not require labelling with the risk phrase R38 "Irritating to the skin," as described in the EEC Directive 83/467/EEC, Annex VI, Part II(D) or the H-statement H315 “Causes skin irritation” according to Regulation (EC) No. 1272/2008.
- Executive summary:
Very slight erythema only was evident in two animals following the removal of the dressings on days 1 and 2. Similar reactions (very slight or well-defined erythema) persisted for a further two to six days before resolving by days 5 or 9. There was no response to treatment in the remaining animal throughout the observation period. A single semi-occlusive application of the test substance to intact rabbit skin for four hours elicited transient slight dermal irritation, but not sufficient that labelling is required with the risk phrase R38 "Irritating to the skin," or H-statement H315 “Causes skin irritation”.
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