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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:
22 Jan 1985 to 12 Feb 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
non-standard rabbit used
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 1,4-Butindiol fest
- Physical state: solid
- Analytical purity: >99%

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian, white Chbb-SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Age at study initiation: no data
- Weight at study initiation: 2.1 (female) and 2.4 kg (male)
- Diet (e.g. ad libitum): K4 Alleindiät für kaninchen, ad libitum
- Water (e.g. ad libitum): tap, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 60
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
Eyes were not rinsed after application. Water-soluble solid.
Observation period (in vivo):
21 days. Observations made at 1, 24, 48, and 72 hours; and 6, 8, 10, 14, 17 and 21 days after application.
Number of animals or in vitro replicates:
6 (3 males / 3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

SCORING SYSTEM: Draize, et. al.

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24 to 72 hours
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: male
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24 to 72 hours
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: male
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24 to 72 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: male
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 4
Time point:
other: 24 to 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: female
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 5
Time point:
other: 24 to 72 hours
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: female
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 6
Time point:
other: 24 to 72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: female
Irritation parameter:
iris score
Basis:
mean
Remarks:
animals 1 and 3
Time point:
other: 24 to 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: males. No effects on iris observed in either animal during any time period.
Irritation parameter:
iris score
Basis:
mean
Remarks:
animals 2, 4, and 5
Time point:
other: 24 to 72 hours
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: Mean score was 0.7 for each of the 3 animals individually, 1 male and 2 females.
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 6
Time point:
other: 24 to 72 hours
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: female
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animals 1, 2, 4, and 5.
Time point:
other: 24 to 72 hours
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: Mean score was 2.3 for each of the 4 animals individually, 2 males and 2 females.
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24 to 72 hours
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: male
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 6
Time point:
other: 24 to 72 hours
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: female
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animals 1 and 2
Time point:
other: 24 to 72 hours
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: males
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animals 3, 4, and 5
Time point:
other: 24 to 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 1 male and 2 females
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 6
Time point:
other: 24 to 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: female
Other effects:
In two animals, iris turned red in parts. In two other animals, iris turned completely red.

Any other information on results incl. tables

Reading

Animal

Cornea

Iris

Conjunctiva Redness

Conjunctiva Chemosis

1 hour

1/2/3/4/5/6

1/1/1/1/1/1

0/0/0/0/0/0

2/2/2/2/2/2

2/2/2/2/2/2

24 hours

1/2/3/4/5/6

1/2/2/2/1/2

0/1/0/1/1/1

3/3/2/3/3/3

1/1/1/1/1/2

48 hours

1/2/3/4/5/6

2/1/2/2/1/2

0/1/0/1/1/1

2/2/2/2/3/3

1/1/0/0/0/1

72 hours

1/2/3/4/5/6

2/1/2/2/0/2

0/0/0/0/0/1

2/2/1/2/1/2

0/0/0/0/0/0

Mean, each animal

1/2/3/4/5/6

1.7/1.3/2.0/ 2.0/0.7/2.0

0.0/0.7/0.0/0.7/0.7/1.0

2.3/2.3/1.7/2.3/2.3/2.7

0.7/0.7/0.3/0.3/0.3/1.0

Mean, all animals

----

1.6

0.5

2.3

0.6

- In two animals, iris turned red in parts. In two other animals, iris turned completely red.

- For 3 female and 1 of the male test animals, all effects on the cornea reversed within 6 days.

- For 2 male test animals, effects on the cornea were slower to reverse and, in 1 male, did not reverse within the 21 day observation period.

Applicant's summary and conclusion

Interpretation of results:
other: Category I (irreversible effects on the eye)
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
1,4-Butynediol should be regarded as an eye irritant capable of causing irreversible effects on the eye based on 1 of 3 males and 0 of 3 female rabbits with a mean cornea score during the 24 to 72 hour time period of 2.0 that did not reverse within 21 days. No secondary infection was reported in the study. Cornea scores for 5 of the 6 test animals were >1, which further supports classification as an eye irritant.