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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: 16 CFR 1500.42
Deviations:
no
Principles of method if other than guideline:
The method was in accordance with the 16 CFR 1500.42 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 / tissue source

Species:
rabbit
Strain:
other: albino ; not otherwise specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Recognised supplier.
- Age at study initiation: Young adults.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 grams
- Concentration (if solution): neat (unchanged)


VEHICLE
- Concentration (if solution): 50% v/v
- Lot/batch no. (if required): not reported.
Duration of treatment / exposure:
3 days
Observation period (in vivo):
4 days (observations were completed every day from day 1 to day 7 post treatment).
Number of animals or in vitro replicates:
6 (sexes not specified)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No.

SCORING SYSTEM: Draize scoring system. Reference 16 CFR 1500.42.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
24
Remarks on result:
other: n = 6; maximum category score = 4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: day 7
Score:
0
Max. score:
24
Remarks on result:
other: n = 6; maximum category score = 4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
12
Remarks on result:
other: n =6; maximum category score = 2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: day 7
Score:
0
Max. score:
12
Remarks on result:
other: n =6 ; maximum category score = 2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
18
Remarks on result:
other: n =6 ; maximum category score = 3; conjunctivae redness - maximum score = 0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: day 7
Score:
0
Max. score:
18
Remarks on result:
other: n =6 ; maximum category score = 3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
24
Remarks on result:
other: n =6 ; maximum category score = 4; chemosis - maximum score = 0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: day 7
Score:
0
Max. score:
24
Remarks on result:
other: n =6 ; maximum category score = 4; chemosis - maximum score = 0
Irritant / corrosive response data:
Following scoring at 24, 48 and 72 h: No positive corneal scores. No positive iridal scores. No positive conjunctivae redness mean scores. No positive chemosis mean scores. All scores for all effect categories were < 1 in all animals on all days (24 to 72hs; and up to 7 days). Discharge positive scores were also absent.

Any other information on results incl. tables

Individual scoring data was presented within the study report. No positive responses observed.

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 would not be considered as an eye irritant.
Executive summary:
The non-GLP study was completed under 16 CFR 1500.42 following a guideline similar to OECD 405, to assess the irritancy potential of the test material to the eye following a single application in the albino rabbit. A mass of 0.1 grams of the test material was placed into one eye in each of 6 animals. The other eye remained untreated and was used for control purposes. Assessment of ocular damage/irritation was made approximately 24, 48 and 72 hours following treatment with observations daily up to 7 days. No corneal opacity or iritis, chemosis or conjunctival redness as observed at any time point up to 7 days in all animals. Under the conditions of this study the test material is not considered to be an eye irritant.