Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an acceptable BASF-test which in principle is similar to OECD 405 (1981), with some deviations (the eyes were not washed out after 24 h); GLP was not compulsory at the time the study was conducted.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
yes
Remarks:
eyes were not washed out after 24 h of treatment
Principles of method if other than guideline:
BASF Test:
Before OECD guideline 405 was established, eye irritation was tested using an BASF internal method. White Vienna rabbits were used. Usually approximately 50 µL of the unchanged test material were applied into the conjunctival sac of one eye of each of 2 animals. The non- or saline- treated eye served as control.The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days. The eyes were not washed out after 24 h as specified in OECD Guideline 405.
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Butyldiäthanolamin
- Physical state: liquid
- Analytical purity: 100%

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
Weight at study initiation: 3.19 and 2.83 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the second eye was treated with NaCl
Amount / concentration applied:
0.05 mL
Duration of treatment / exposure:
The test substance were applied unchanged to the rabbit eyes, and the eyes were not washed out.
The eyes were examined after

Observation period (in vivo):
8 days
reading time points: after 10 minutes, 1 h, 3 h, 24 h, 48 h and 72 h, and at day 6, 7 and 8.
Number of animals or in vitro replicates:
one male and one female animal
Details on study design:
Following application, the animals were examined for corneal changes, iris effects and conjunctival reaction at the reading time points mentioned above. The eye findings, which had been originally scored according to a BASF scoring system were re-evaluated according to the Draize Scoring System.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: same finding at all reading time points given above
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: same finding at all reading time points given above
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: constricted pupil, bleeding, detachment of the upper skin layer, bloody discharge, grey-brown signs of corrosion; same findings at all reading time points given above
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: slight swelling, same finding at all reading time points given above
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: same finding at all reading time points given above
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: same finding at all reading time points given above
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: constricted pupil, bleeding, detachment of the upper skin layer, bloody discharge, grey-brown signs of corrosion; same findings at all reading time points given above
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: swelling, same finding at all reading time points given above
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of the 2 animals
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
of the 2 animals
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
of the 2 animals
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of the 2 animals
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
Animal 1:
At day 6, findings were as already described with in addition, scarring at the upper eyelid.
At day 7, findings were as already described with in addition, scarring at the upper eyelid, conjunctiva becoming grey-white, bleeding, slight to milky opacity of the cornea, and vascular ingrowth.
At day 8, findings were as reported above, with in addition onset of staphyloma; thus there was no evidence for reversibility of the findings.
Control eyes treated with physiological saline remained free from effects.

Animal 2:
At day 6, findings were as already described with in addition, scarring at the upper eyelid, slight to milky opacity of the cornea, vascular ingrowth and onset of staphyloma.
At day 7, findings were similar as for day 6.
At day 8, findings were as reported above, with clear staphyloma; thus there was no evidence for reversibility of the findings.
Control eyes treated with physiological saline remained free from effects.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
CLP: Cat 1
DSD: R 34
Executive summary:

Butyldiethanolamine was tested for eye irritation in the rabbit according to an internal BASF method, which in principle was similar to the OECD TG 405 (1981). Approximately 50 µL of the unchanged test material were applied into the conjunctival sac of one eye of each of 2 rabbits. The saline-treated eye served as control.The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days. The eyes were not washed out after 24 h as specified in OECD Guideline 405. The findings were evaluated according to the Draize Scoring System.

The instillation of the test material into the eye of rabbit resulted in severe irreversible lesions.