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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Pre-GLP study following a method equivalent to a recognised OECD guideline. Deviations to recognised guideline are noted.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Occlusive dressing smaller exposure area (ca. 2.5cm2), longer exposure period (24h) shorter observation period (48h)
Qualifier:
according to guideline
Guideline:
other: 16 CFR 1500.41
Deviations:
no
Principles of method if other than guideline:
The method was in accordance with the 16 CFR 1500.41 and US CPSC requirements
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of (1RS,3RS)-3-methyl-3-(4-methylpentyl)cyclohexyl acetate and (2RS,4aRS,8aSR)-5,5,8a-trimethyldecahydro-2-naphthalenyl acetate and (2RS,4aRS,8aRS)-5,5,8a-trimethyldecahydro-2-naphthalenyl acetate
Molecular formula:
not applicable (reaction mass of constitutional isomers)
IUPAC Name:
Reaction mass of (1RS,3RS)-3-methyl-3-(4-methylpentyl)cyclohexyl acetate and (2RS,4aRS,8aSR)-5,5,8a-trimethyldecahydro-2-naphthalenyl acetate and (2RS,4aRS,8aRS)-5,5,8a-trimethyldecahydro-2-naphthalenyl acetate
Test material form:
other: liquid
Details on test material:
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
other: albino; not otherwise specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: Not reported.
- Weight at study initiation: Not reported.
- Housing: Not reported.
- Diet: rabbit chow ad libitum
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported.
- Humidity (%): Not reported.
- Air changes (per hr): Not reported.
- Photoperiod (hrs dark / hrs light): Not reported.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped / abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): neat (liquid)
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 (sexes not specified)
Details on study design:
TEST SITE
- Area of exposure: According to 16 CFR 1500.41
- % coverage: Not reported. A group of six albino rabbits was clipped over a wide area. One side of the animals' backs was abraded at one site with a lancet sufficiently deep to penetrate the stratum corneum but not enter the derma to produce bleeding. The skin of the other side was allowed to remain intact.
- Type of wrap if used: Occlusive (gauze wrapped with impervious material)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not reported
- Time after start of exposure: Not applicable.

SCORING SYSTEM: Draize-scoring system. References: 16 CFR 1500.41 and 16 CFR 1500.3.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
0.12
Max. score:
8
Reversibility:
no data
Remarks on result:
other: intact and abraded skin
Irritant / corrosive response data:
Intact skin: Very slight edema (barely perceptible) response in animal #3. Abraded skin: Very slight (barely perceptible) erythema and very slight edema (barely perceptible) was noted during the observation period in animal #3. All reactions fully reversed at 72 hours.

Any other information on results incl. tables

Table 1. Skin reactions (using Draize scoring method)

Erythema & Eschar Formation Hours Rabbit number Mean score
1 2 3 4 5 6
Intact skin 24 0 0 0 0 0 0 0.00
72 0 0 0 0 0 0 0.00
Abraded skin 24 0 0 1 0 0 0 0.17
72 0 0 0 0 0 0 0.00
 
Edema                
Intact skin 24 0 0 1 0 0 0 0.17
72 0 0 0 0 0 0 0.00
Abraded skin 24 0 0 0 0 0 0 0.00
72 0 0 0 0 0 0 0.00
                 
Sum of mean scores 0.51
Primary irritation index = sum of mean scores/4 0.12

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
Under the conditions of this study the test substance is not considered to be irritating to the skin.
Executive summary:

The non-GLP study was completed under 16 CFR 1500.41 following a guideline similar to OECD 404, to assess the irritancy potential of the test material to the skin of the albino rabbit. The test substance was evaluated in 6 albino rabbits. A dose of 0.5 g test substance was applied to intact and abraded clipped dorsal skin site under a occlusive dressing for 24 hours. Skin observations were made 24 and 72 hours after patch removal. Very slight edema were noted at 24 hours in both intact and abraded skin in animal #3. Very slight erythema and edema were seen in abraded skin in animal #3. All other organisms gave negative responses. By 72 hours, all responses had fully reversed in both intact and abraded skin. The test material produced a mean primary irritation index (PII) of 0.12 and is considered to be non-irritating to skin.