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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
18 November 1980 - 12 December 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
The procedure followed was a modification of that desribed by Draize
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Lanolin alcohols
IUPAC Name:
Lanolin alcohols
Constituent 2
Reference substance name:
Alcohols, lanolin
EC Number:
232-430-1
EC Name:
Alcohols, lanolin
Cas Number:
8027-33-6
Molecular formula:
UVCB
Details on test material:
- Name of test material (as cited in study report): Lanolin alcohol
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: about 3 months
- Weight at study initiation: 2 kg
- Housing: housed in galvanised or stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Animals were acclimitised at least 3 days prior to test initiation

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
not specified
Controls:
other: yes, the other eye was used for control purposes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
72 h
Reading time points: 24, 48 and 72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): If any of the test article remained in the eye for 24 hours, the eye was washed out with lukewarm water after the 24 hour reading.
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: mean after 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: mean after 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: mean after 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of all 6 animals
Time point:
other: mean after 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
The test material showed no effects to either the cornea, iris or conjuctivae.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not an ocular irritant to rabbits under the conditions of the test.
CLP: not classified
DSD: not classified
Executive summary:

The test substance is not an occular irritant to rabbits under the conditions of the test.