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Registration Dossier
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EC number: 701-039-2 | CAS number: 156324-78-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-08-31 to 1992-09-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Deviations from the OECD 404 (2015): 4 animals were tested instead of 3 animals. Systemic effects were not investigated. 5 test item concentrations were tested simultaneously (undiluted, 1, 5, 10, & 20 %) with each rabbit. 30 min. observation was conducted instead of a 1 h observation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981-05-12
- Deviations:
- yes
- Remarks:
- 4 animals were tested instead of 3 animals. Systemic effects were not investigated. 5 test item concentrations were tested simultaneously (undiluted, 1, 5, 10, & 20 %) with each rabbit.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[({[(1R,2S,5R)-5-methyl-2-(propan-2-yl)cyclohexyl]oxy}carbonyl)oxy]ethan-1-ol
- EC Number:
- 701-039-2
- Cas Number:
- 156324-78-6
- Molecular formula:
- C13H24O4
- IUPAC Name:
- 2-[({[(1R,2S,5R)-5-methyl-2-(propan-2-yl)cyclohexyl]oxy}carbonyl)oxy]ethan-1-ol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Mol:Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - SPF albino rabbits
- Weight at study initiation: 2.2 - 2.7 kg
- Housing: kept in single PPL cages, 45 x 55 cm, with perforated floor
- Diet (ad libitum): feed pellets "Altromin 2123"
- Water (ad libitum): drinking water acidified with hydrochloric acid to pH 2.5
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3°C
- Relative humidity: 55 ± 15%
- Air changes: 10 times/hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: Diethyl phthalate (DEP)
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the undiluted test substance moistened with the vehicle
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
VEHICLE CONTROL
- Amount(s) applied (volume or weight): 0.5 mL of the vehicle - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 4 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: area of 10 x 10 cm on the back
- Type of wrap if used: to a patch (2.5 x 2.5 cm) the test substance was applied and the patch were placed on the back. The gauze patch was secured with adhesive type and fixed with Scanpor tape loosely wound round the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing: treated skin was cleaned with soap and lukewarm water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
30 minutes as well as 24, 48, and 72 hours after application
SCORING SYSTEM: according to the Draize scale
- Method of calculation: scores for erythema and oedema formation for the last 3 readings of each rabbit (24, 48 and 72 hours) for each test concentration were obtained separately and divided by 3. The results are the mean scores for erythema and oedema formation of the individual rabbit.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- At the 24 hour observation very slight erythema was observed at two test sites with a 100% test concentration.
Any other information on results incl. tables
TEST CONCENTRATION: 20 %
At the 24 hour observation very slight erythema (score 1) was observed at one test site treated with a 20% test concentration.
TEST CONCENTRATIONS: 10 %, 5 %, and 1 %
No skin reactions were observed after test item applications, except for very slight oedema (barely perceptible) (score 1) at one test site treated with the 1 % test concentration during the 30 minute observation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the skin based on an in vivo study (OECD 404).
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin irritant. - Executive summary:
The skin irritation potential of the substance was investigated according to the OECD guideline 404. A single dose of 0.5 g of the substance moistened with the vehicle was applied to the skin of four female Mol: Russian rabbits and covered semi-occlusive for an exposure period of 4 hours. In addition the vehicle alone was also applied to the skin of the rabbits. The test sites were examined for skin reactions after test item treatment and scored according to the Draize scale after 30 minutes as well as 24, 48 and 72 hours after application.
The following results were recorded:
Animal #1
Erythema: 0
Oedema: 0
Animal #2
Erythema: 0.33
Oedema: 0
Animal #3
Erythema: 0
Oedema: 0
Animal #4
Erythema: 0.33
Oedema: 0.33
At the 24 hour observation very slight erythema (score 1) was observed at two test sites. No further skin reactions were observed.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin irritant.
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