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Toxicological information

Skin irritation / corrosion

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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:
1992
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

Constituent 1
Chemical structure
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

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.