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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:
1985/07/22-1985/07/25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented study report which meets basic scientific principles: GLP
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1985/07/22-1985/07/25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well-documented study report which meets basic scientific principles: GLP
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose:
read-across source
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no 72 hour observation, but material demonstrated no irritation at 24 and 48 hours
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ranch Rabbits
- Sex: 3 females
- Weight at study initiation: 2.4 to 3.0 kg
- Housing: Individually
- Diet (e.g. ad libitum): Guinea Pig Maintenance Diet, from Special Diet Services, ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 46-71
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated contra-lateral eye
Amount / concentration applied:
Amount(s) applied (volume or weight): 0.1 ml
Concentration (if solution): neat
Duration of treatment / exposure:
Test material was introduced into one eye of each animal. The eyelids were held together for approximately one second, and then released to allow observation of the reaction of the animal.
Observation period (in vivo):
1, 24, and 48h post instillation and once per day on days 4 and 7. For each observation, reference was made to the contra-lateral (untreated) eye.
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
SCORING SYSTEM: Draize scale for ocular irritation.

The presence of damage to the tissues of the eye was investigated by fluorescein staining at each observation except those on the day of exposure. Any ocular reactions not adequately described by the scoring system or in structures not mentioned were recorded in full. At the completion of the observation period the rabbits were killed by cervical dislocation.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 hour
Score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 hour
Score:
1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48 h
Score:
0
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: no irritation was noted after the 1 hour observation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Mean score at 24-48 hour observation was 0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Mean score at 24-48 hour observation was 0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Mean score at 24-48 hour observation was 0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Mean score at 24-48 hour observation was 0
Irritant / corrosive response data:
All animals exhibited a conjunctival redness score of 1 at the 1 hour time point. All irritation scores were zero at the 24 and 48 hour observation time points.
Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The mean (24-48 hour) corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for BP83HP were 0, 0, 0, and 0 respectively. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

This study was conducted to determine the potential of BP83HP to cause irritation to the eye in a rabbit model system. The eyes of six rabbits were instilled with 0.1 ml of BP83HP, neat. Ocular examinations occurred at 1h, 24h, and 48h post instillation. Ocular damage was assessed and scored according to the Draize method. All animals survived the exposure. There was slight irritation noted (conjunctivae score of 1) at the 1 hour observation point. There was no irritation at the 24 and 48 hour observations. The mean (24-48 hour) corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for BP83HP were 0, 0, 0, and 0 respectively. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
no 72 hour observation, but material demonstrated no irritation at 24 and 48 hours
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ranch Rabbits
- Sex: 3 females
- Weight at study initiation: 2.4 to 3.0 kg
- Housing: Individually
- Diet (e.g. ad libitum): Guinea Pig Maintenance Diet, from Special Diet Services, ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 46-71
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated contra-lateral eye
Amount / concentration applied:
Amount(s) applied (volume or weight): 0.1 ml
Concentration (if solution): neat
Duration of treatment / exposure:
Test material was introduced into one eye of each animal. The eyelids were held together for approximately one second, and then released to allow observation of the reaction of the animal.
Observation period (in vivo):
1, 24, and 48h post instillation and once per day on days 4 and 7. For each observation, reference was made to the contra-lateral (untreated) eye.
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
SCORING SYSTEM: Draize scale for ocular irritation.

The presence of damage to the tissues of the eye was investigated by fluorescein staining at each observation except those on the day of exposure. Any ocular reactions not adequately described by the scoring system or in structures not mentioned were recorded in full. At the completion of the observation period the rabbits were killed by cervical dislocation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 hour
Score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 hour
Score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 hour
Score:
1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48 h
Score:
0
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: no irritation was noted after the 1 hour observation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Mean score at 24-48 hour observation was 0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Mean score at 24-48 hour observation was 0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Mean score at 24-48 hour observation was 0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Mean score at 24-48 hour observation was 0
Irritant / corrosive response data:
All animals exhibited a conjunctival redness score of 1 at the 1 hour time point. All irritation scores were zero at the 24 and 48 hour observation time points.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The mean (24-48 hour) corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for BP83HP were 0, 0, 0, and 0 respectively. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

This study was conducted to determine the potential of BP83HP to cause irritation to the eye in a rabbit model system. The eyes of six rabbits were instilled with 0.1 ml of BP83HP, neat. Ocular examinations occurred at 1h, 24h, and 48h post instillation. Ocular damage was assessed and scored according to the Draize method. All animals survived the exposure. There was slight irritation noted (conjunctivae score of 1) at the 1 hour observation point. There was no irritation at the 24 and 48 hour observations. The mean (24-48 hour) corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for BP83HP were 0, 0, 0, and 0 respectively. Classification as an ocular irritant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.