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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (limited details on test substance purity, only 72h observation period and limited documentation).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
: Lack of study details, no eye examination previous to start, 6 animals used
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
limited details on test substance purity, only 72h observation period and limited documentation
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tetradecanoic acid, 1-methylethyl ester
- Analytical purity: no data

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:
single instillation without washout
Observation period (in vivo):
72 hours
Reading time points: 24, 48 and 72 h
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:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0.22
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: reactions in 4 animals at 24h only
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable

Any other information on results incl. tables

Table 1: Individual irritation scores:

Animal Number

Hours after Application

24

48

72

A

B

C

D

A

B

C

D

A

B

C

D

1

0

0

1

0

0

0

0

0

0

0

0

0

2

0

0

0

0

0

0

0

0

0

0

0

0

3

0

0

0

0

0

0

0

0

0

0

0

0

4

0

0

1

0

0

0

0

0

0

0

0

0

5

0

0

1

0

0

0

0

0

0

0

0

0

6

0

0

1

0

0

0

0

0

0

0

0

0

A = Cornea Score

B = Iris Score

C = Conjunctiva Score

D = Chemosis Score

After instillation of the test substance in rabbit eyes, four animals showed slight erythema 24 h after application but after 48 h, all test animals were without any signs of irritation on the treated eyes. 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
Conclusions:
CLP: not classified
DSD: not classified