Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
29 December 1987 to 18 January 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline and GLP-compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Ethyl butyl propanediol
- Physical state: colourless crystalline powder
- Analytical purity: 98.2%
- Storage conditions: at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Rabbits were supplied by Rosemead Rabbits, Waltham Abbey, Essex, England. They were 12 to 13 weeks old and had a weight range of 2.8 to 3.2 kg, prior to treatment on Day 1. The animal room temperature was maintained at 19°C with a relative humidity at 30-70%. Air exchange was maintained at 19 air changes/hour and lighting was controlled to give 12 hours of artificial light (7:00 - 19:00) in each 24 hour period.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL (80 mg)
Duration of treatment / exposure:
N/A, no rinse after instillation
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Details on study design:
Ocular reactions were assessed at 1 hour and 1, 2, 3, 4, 7, and 14 days after instillation. Observation of the eyes was aided by the use of a handheld torch. The contralateral, untreated eye, acted as the integral control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-72h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 14d
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-7h
Score:
0.22
Max. score:
2
Reversibility:
fully reversible within: 7d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72h
Score:
1.67
Max. score:
3
Reversibility:
fully reversible within: 14d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72h
Score:
1.22
Max. score:
4
Reversibility:
fully reversible within: 14 d
Irritant / corrosive response data:
The group mean scores for ocular reactions did not exceed the classification thresholds and so classification as an ocular irritant is not required. No reactions persisted to the conclusion of the study.
See table below.
Other effects:
Easily discernible corneal opacities were seen in two of the animals. A diffuse opacity was seen in the third. Iritis was observed in only one animal 24-72 hours after instillation. A diffuse crimson colouration of the conjunctivae, accompanied by obvious swelling with partial eversion of the lids was observed in all three animals. All eyes were normal 7 or 14 days after instillation of the test material.

Any other information on results incl. tables

Scores for eye irritation

Rabbit number

Region of eye

One hour

Days after instillation

1 (24 h)

2 (48 h)

3 (72 h)

4

7

14

 

1792F

Cornea

0

2

1

1

0

0

0

Iris

0

0

0

0

0

0

0

Conjunctivae

Redness

1

2

2

1

1

0

0

Chemosis

2

2

1

1

0

0

0

 

1793F

Cornea

1

1

2

2

2

2

0

Iris

0

0

1

1

1

0

0

Conjunctivae

Redness

1

2

2

2

2

1

0

Chemosis

2

2

1

1

1

1

0

 

1818F

Cornea

0

1

1

1

1

0

-

Iris

0

0

0

0

0

0

-

Conjunctivae

Redness

2

2

1

1

1

0

-

Chemosis

2

1

1

1

0

0

-

Mean scores for 24 – 72 hours

Cornea

1.33

Iris

0.22

Conjunctival redness

1.67

Conjuctival chemosis

1.22

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
BEPD was found to be irritating to the eye under the conditions of the study and requires classification (Category 2) under CLP.
Executive summary:

Three New Zealand White Rabbits were treated with 0.1 mL (80 mg) of the test material, which was placed into the lower everted lid of one eye of each rabbit. The contralateral eye was left untreated and served as a control. Assessment of ocular damage/irritation was made at 1 hour and 1, 2, 3, 4, 7, and 14 days after instillation. Easily discernible corneal opacities were seen in two of the animals. A diffuse opacity was seen in the third. Iritis was observed in one animal only two days after installation. A diffuse crimson colouration of the conjunctivae, accompanied by obvious swelling with partial eversion of the lids was observed in all three animals. All eyes were normal seven or fourteen days after instillation of the test material. BEPD was found to be an eye irritant under the conditions of the study and requires classification (Category 2) under CLP.