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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05 Oct - 13 Oct 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study similar to guideline study with the acceptable restrictions
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
(reduced test volume of 50 µL; observation period 8 days; no reading at 72 hrs; 2 test animals used)
Principles of method if other than guideline:
Internal method (BASF test): 2 test animals, applied volume 50 µL , scoring at 1, 3, 24, and 48 hrs, and 5, 7, and 8 days after instillation; scores converted to grades according to Draize
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
3,7-Dimethyloctadien-2,6-al-1
Purity: >= 95 %

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.19 and 2.01 kg
- Sex: females

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the respective animal
Duration of treatment / exposure:
not applicable; eyes were not washed out after 24 h as recommended in the OECD Guideline 405
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no

OBSERVATIONS
- after 1 and 3 hours, 1, 2, 5, 7 and 8 days

SCORING SYSTEM:
- The original BASF grading was converted into the numerical grading according to the OECD Draize system.

TOOL USED TO ASSESS SCORE:
- fluorescein, at the end of the study

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 and 48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 and 48 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 and 48 h
Score:
1.5
Max. score:
3
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
other: 24 and 48 h
Score:
1.25
Max. score:
4
Reversibility:
fully reversible within: 7 d
Irritant / corrosive response data:
For details see Table:
Both animals showed an opacity of the cornea of grade 1 after 24 and 48 hrs and on day 5. Thereafter this finding was completely reversible.
Findings of the conjunctiva were redness which persisted in both animals throughout the whole observation period (grade 1 with the exception of a grade 2 score in one animal at 24 and 48 hrs). Chemosis was observed after 24 and 48 hrs and after 5 days (grade 1 except for grade 2 in one animal at 24 hrs) and was reversible thereafter. Scar formation on the conjunctiva was observed after 24 hrs in both animals. During the further observation period this finding was present only in one animal on days 2, 5 and 7.
Additionally, secretion was reported from 24 hrs up to 5 days (grade 1).

Any other information on results incl. tables

Table: Scores for changes of the cornea, iris and conjunctiva:

 Readings  animal  cornea  iris        conjunctiva
     opacity/area    redness  chemosis  secretion
1 h 0/0  1 0
  0/0 
3 h  1 0/0  0
0/0  0
24 h  1/4  1* 
1/4  2* 
48 h 1/4  1
  1/4  2* 
 5 d 1/2 
  1/1  1* 
 7 d 0/0 0
  0/0  0 1* 
 8 d 0/0  0  0
  0/0  0  0 0

 Mean 24 h, 48 h

 1  1/4 0  1  1  
   2  1/4 0  2  1.5  
 Mean 24 h, 48 h  1 - 2  1/4  0  1.5  1.25  

* scar

Observations after 8 days with fluorescein: no findings

Control eyes: no findings

Applicant's summary and conclusion