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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:
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 for cross-reference:
read-across: supporting information
Reference
Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
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 for cross-reference:
read-across source
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No corneal damage or iridial inflammation was observed. Only slight signs of irritation were observed in the rabbits.

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 Sample V 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:

This data is being read across from the source study that tested Hydrocarbons, C10-C12, isoalkanes, <2% aromatics based on analogue read across.

Sample V (0.1 mL, neat) was administered to the right eye of three rabbits to assess for 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. Only slight signs of irritation were observed in the rabbits. The mean conjunctivae, chemosis, iris, and cornea scores for sample V 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:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Hydrocarbons, C10-C12, isoalkanes, <2% aromatics
EC Number:
923-037-2
Molecular formula:
(CH2)6-8C4H10
IUPAC Name:
Hydrocarbons, C10-C12, isoalkanes, <2% aromatics

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:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No corneal damage or iridial inflammation was observed. Only slight signs of irritation were observed in the rabbits.

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 Sample V 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:

Sample V (0.1 mL, neat) was administered to the right eye of three rabbits to assess for 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. Only slight signs of irritation were observed in the rabbits. The mean conjunctivae, chemosis, iris, and cornea scores for sample V 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.

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