Registration Dossier
Registration Dossier
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EC number: 944-855-6 | CAS number: 199445-85-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From the 4th June 1991 to the 25th April 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The methodology used in this study was equivalent to the current guideline requirements at the time the study was conducted. Although there are some minor deficiencies in reporting compared to modern requirements, the study is considered suitable as a key study for skin irritation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not applicable
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The procedures used in this study were designed to meet the requirements of the test for skin irritation described within document L251, sn EEC Commission Directive of 25 April 1984.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of (3R)-3-[(1R)-4-methyl-3-cyclohexen-1-yl]butanal and (3S)-3-[(1R)-4-methyl-3-cyclohexen-1-yl]butanal
- EC Number:
- 944-855-6
- Cas Number:
- 199445-85-7
- Molecular formula:
- Not applicable (reaction mass of stereochemical isomers)
- IUPAC Name:
- Reaction mass of (3R)-3-[(1R)-4-methyl-3-cyclohexen-1-yl]butanal and (3S)-3-[(1R)-4-methyl-3-cyclohexen-1-yl]butanal
- Test material form:
- liquid
- Details on test material:
- Test Item Storage: +4 °C in the dark
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 4 ºC / Dark
- Stability under test conditions: Assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: N/A
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: N/A
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: Recognised supplier
-Housing: In grid bottomed metal cages
-Diet: SQC standard rabbit pellets
-Water: main drinking water via automated watering system
-Acclimation period: 5 days
ENVIRONMENTAL CONDITION
-Temperature: 17 -21°C
-Humidity: 46 - 65%
-Air changes (per hour): Air conditioned
Photoperiod (hrs dark/hrs light): 12 hrs dark/12 hrs light
Test system
- Type of coverage:
- semiocclusive
- 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:
- observation was made after one, 24, 48, and 72 hours and 7 then 14days.
- Number of animals:
- 4
- Details on study design:
- The day befoe dose the animals were placed in a restraining stocks and the dorsal surface of the trunk was clipped free of fur using an Oster Model A2 clipper with Angra blade.
On the day of doseing the animals were placed in a restraining stocks. 0.5ml aliqout of the test item was placed evenly over a 2.5 cm square of surgical lint. the lint was placed over the dorsal skin of the animal, the test item was held in contact with the skin under a semi-occlusive patch for 4 hour period. After which the patches were removed and skin reaction assesd after 1, 24, 48, and 72 hours and 7 and 14 days.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Mild inflamation observed during 7 day period but all effected had dissipated by 14 days.
Any other information on results incl. tables
1 Hour Observation
|
24 Hour Observation
|
48 Hour Observation
|
72 Hour Observation
|
7 Day Observation
|
14 Day Observation
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was concluded to be non irritant to the skin.
- Executive summary:
The skin irritation potential of the test substance was evaluated using a method similar to OECD 404 and in accordance with GLP. In the test, 0.5 ml of the test item was applied to the clipped dorsal skin of 4 albino rabbits under semi-occlusion for a 4 hour period. Mild inflammation on day 7 was observed, which disappeared by day 14. From the result of the study, it was concluded that the test item would not require classification as a skin irritant.
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