Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions, basic data given

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
limited documentation, analytical purity of test substance not specified
Principles of method if other than guideline:
Protocol according to FHSA
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropyl palmitate
EC Number:
205-571-1
EC Name:
Isopropyl palmitate
Cas Number:
142-91-6
Molecular formula:
C19H38O2
IUPAC Name:
propan-2-yl hexadecanoate
Details on test material:
- Name of test material (as cited in study report): Isopropyl palmitate
- Name of test material (as cited in study report): Hexadecanoic acid, 1-methylethyl ester
- CAS No. of test material (as cited in study report): 142-91-6

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:
24h
Observation period (in vivo):
1, 24, 48 and 72h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE: no

SCORING SYSTEM: according to Draize scale for scoring ocular lesions

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: average 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: no effects in any animal
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: average 24, 48 and 72h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
other: no effects in any animal
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: average 24, 48 and 72h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: average 24, 48 and 72h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 48h

Any other information on results incl. tables

Individual Scores:

Animal Number

Hours after Application

1

24

48

72

A

B

C

D

A

B

C

D

A

B

C

D

A

B

C

D

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2

0

0

1

1

0

0

1

1

0

0

1

0

0

0

0

0

3

0

0

1

0

0

0

1

0

0

0

1

0

0

0

0

0

4

0

0

1

1

0

0

0

0

0

0

0

0

0

0

0

0

5

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

6

0

0

1

1

0

0

1

0

0

0

1

0

0

0

0

0

A = Cornea Score

B = Iris Score

C = Conjunctiva Score

D = Chemosis Score

After a single instillation the test substance causes mild irritations to rabbit eyes that were fully reversible within 72h. According to DSD and CLP the test substance has not to be classified.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU