Registration Dossier

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:
2000/03/08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline 405: 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:
2000/03/08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report equivalent or similar to OECD guideline 405: 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:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd
- Age at study initiation: 13 weeks
- Weight at study initiation: 2.7 - 3.2 kg
- Housing: individual
- Diet (e.g. ad libitum): Special Diet Services STANRAB SQC pellet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 25 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 -23
- Humidity (%): 36-45
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral eye
Amount / concentration applied:
0.1mL
Duration of treatment / exposure:
The eyelids were gently held together for one second before releasing.
Observation period (in vivo):
1, 24, 48, and 72 hours post-treatment
Number of animals or in vitro replicates:
3
Details on study design:
Test material was applied to the eyes and the eyelids were gently held together for one second before releasing. Irritation and toxicity were monitored at 1, 24, 48, and 72 hours post-treatment. Irritation was scored according to the Draize methodology.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 hour
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 hour
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 -72 hour
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 -72 hour
Score:
0
Max. score:
0
Irritant / corrosive response data:
No corneal damage or iridial inflammation was observed. Hyperaemia of blood vessels of the conjuctivae was seen in all animals. Ocular reactions had resolved in all instances by one day after instillation.

Irritation parameter Basis Time Point Score
conjuctivae score animal #1 24 hours 0
conjuctivae score animal #2 24 hours 0
conjuctivae score animal #3 24 hours 0
conjuctivae score animal #1 48 hours 0
conjuctivae score animal #2 48 hours 0
conjuctivae score animal #3 48 hours 0
conjuctivae score animal #1 72 hours 0
conjuctivae score animal #2 72 hours 0
conjuctivae score animal #3 72 hours 0
conjuctivae score mean 24 hour mean 0
conjuctivae score mean 48 hour mean 0
conjuctivae score mean 72 hour mean 0
conjuctivae score mean 24-72 hour mean 0
chemosis score animal #1 24 hours 0
chemosis score animal #2 24 hours 0
chemosis score animal #3 24 hours 0
chemosis score animal #1 48 hours 0
chemosis score animal #2 48 hours 0
chemosis score animal #3 48 hours 0
chemosis score animal #1 72 hours 0
chemosis score animal #2 72 hours 0
chemosis score animal #3 72 hours 0
chemosis score mean 24 hour mean 0
chemosis score mean 48 hour mean 0
chemosis score mean 72 hour mean 0
chemosis score mean 24-72 hour mean 0
cornea score mean 24-72 hour mean 0
iris score mean 24-72 hour mean 0
Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The mean conjunctivae, chemosis, iris, and cornea scores for the Petrepar 134 (60/40) were 0.0, 0.0, 0.0, and 0.0 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:

Petrepar 134 (60/40) (0.1 mL, neat) was administered to the right eye of three rabbits to assess occular irritation. Irritation and toxicity were monitored at 1, 24, 48, and 72 hours post-treatment. Irritation was scored according to the Draize methodology. No corneal damage or iridial inflammation was observed. Hyperaemia of blood vessels of the conjuctivae was seen in all animals. Ocular reactions had resolved in all instances by one day after instillation. The mean conjunctivae, chemosis, iris, and cornea scores for the Petrepar 134 (60/40) were 0.0, 0.0, 0.0, and 0.0 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:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
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: Harlan UK Ltd
- Age at study initiation: 13 weeks
- Weight at study initiation: 2.7 - 3.2 kg
- Housing: individual
- Diet (e.g. ad libitum): Special Diet Services STANRAB SQC pellet, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 25 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 -23
- Humidity (%): 36-45
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral eye
Amount / concentration applied:
0.1mL
Duration of treatment / exposure:
The eyelids were gently held together for one second before releasing.
Observation period (in vivo):
1, 24, 48, and 72 hours post-treatment
Number of animals or in vitro replicates:
3
Details on study design:
Test material was applied to the eyes and the eyelids were gently held together for one second before releasing. Irritation and toxicity were monitored at 1, 24, 48, and 72 hours post-treatment. Irritation was scored according to the Draize methodology.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 hour
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-72 hour
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 -72 hour
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 -72 hour
Score:
0
Max. score:
0
Irritant / corrosive response data:
No corneal damage or iridial inflammation was observed. Hyperaemia of blood vessels of the conjuctivae was seen in all animals. Ocular reactions had resolved in all instances by one day after instillation.

Any other information on results incl. tables

Irritation parameter Basis Time Point Score
conjuctivae score animal #1 24 hours 0
conjuctivae score animal #2 24 hours 0
conjuctivae score animal #3 24 hours 0
conjuctivae score animal #1 48 hours 0
conjuctivae score animal #2 48 hours 0
conjuctivae score animal #3 48 hours 0
conjuctivae score animal #1 72 hours 0
conjuctivae score animal #2 72 hours 0
conjuctivae score animal #3 72 hours 0
conjuctivae score mean 24 hour mean 0
conjuctivae score mean 48 hour mean 0
conjuctivae score mean 72 hour mean 0
conjuctivae score mean 24-72 hour mean 0
chemosis score animal #1 24 hours 0
chemosis score animal #2 24 hours 0
chemosis score animal #3 24 hours 0
chemosis score animal #1 48 hours 0
chemosis score animal #2 48 hours 0
chemosis score animal #3 48 hours 0
chemosis score animal #1 72 hours 0
chemosis score animal #2 72 hours 0
chemosis score animal #3 72 hours 0
chemosis score mean 24 hour mean 0
chemosis score mean 48 hour mean 0
chemosis score mean 72 hour mean 0
chemosis score mean 24-72 hour mean 0
cornea score mean 24-72 hour mean 0
iris score mean 24-72 hour mean 0

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The mean conjunctivae, chemosis, iris, and cornea scores for the Petrepar 134 (60/40) were 0.0, 0.0, 0.0, and 0.0 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:

Petrepar 134 (60/40) (0.1 mL, neat) was administered to the right eye of three rabbits to assess occular irritation. Irritation and toxicity were monitored at 1, 24, 48, and 72 hours post-treatment. Irritation was scored according to the Draize methodology. No corneal damage or iridial inflammation was observed. Hyperaemia of blood vessels of the conjuctivae was seen in all animals. Ocular reactions had resolved in all instances by one day after instillation. The mean conjunctivae, chemosis, iris, and cornea scores for the Petrepar 134 (60/40) were 0.0, 0.0, 0.0, and 0.0 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.