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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Grey literature deficient in some details of methodology but considered adequate for the purposes of hazard identification and classification.

Data source

Reference
Reference Type:
grey literature
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)
Deviations:
yes
Remarks:
no assessment of iris effects
Principles of method if other than guideline:
Pre-dates but broadly comparable to OECD 405
GLP compliance:
no
Remarks:
pre-dates GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No information available

Test system

Vehicle:
other: Applied undiluted and as a 5% concentration in diethyl phthalate
Controls:
other: The untreated eyes of each rabbit served as controls
Amount / concentration applied:
0.1mL
Duration of treatment / exposure:
No information
Observation period (in vivo):
Observations of the eyes were made immediately and 1, 2, 4, 24, 48 and 72 hours later. Fluorescein was used to check corneal damage. Scoring of the eyes was done by the method of Draize.
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
No additional details

Results and discussion

Results of in vivo studyopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
(undiluted)
Basis:
mean
Time point:
other: mean 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant, no effects observed
Remarks on result:
other: o corneal findings were reported in any rabbit
Irritation parameter:
conjunctivae score
Remarks:
(undiluted)
Basis:
mean
Time point:
other: Mean 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: Initial conjunctival erythem (Grade 1) had resolved by 24 hours
Irritation parameter:
chemosis score
Remarks:
(undiluted)
Basis:
mean
Time point:
other: Mean 24, 38, 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant, no effects observed
Remarks on result:
other: No chemosis was observed in any rabbit
Other effects:
No information available

Any other information on results incl. tables


Undiluted  Linalyl Isobutyrate
 At instillation        1 Hour        2 Hours        4 Hours        24 Hours        48 Hours        72 Hours        
 Rabbit  A  B  C  A  B  C  A  B  C  A  B  C  A  B  C  A  B  C  A  B  C  

Cornea- Opacity

 0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  
Cornea- Area Involved  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  
Pupil Reaction  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  
 Conjunctiva- Redness 1  1  1  1 1  1  1  0  0  1  0  0  0  0  0  0  0  0  0  0  0  
 Conjunctiva- Chemosis  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  
 Conjunctiva- Discharge        0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  
 

5% Linalyl Isobutyrate   Instillation         1 Hour         2 Hours        4 Hours        24 Hours        48 Hours         72 Hours        
 Rabbit  A  B  C  A  B  C  A  B  C  A  B  C  A  B  C  A  B  C  A  B  C  

Cornea- Opacity

 0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  
Cornea- Area Involved  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  
Pupil Reaction  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  +  
 Conjunctiva- Redness 1  1  1  0 0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  
 Conjunctiva- Chemosis  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  
 Conjunctiva- Discharge        0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0  0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Undiluted Linalyl Isobutyrate was found to be a minimal eye irritant under the conditions of this study and does not require classification as an eye irritant according to the CLP Regulation.
Executive summary:

Instillation of 0.1 mL undiluted Linalyl Isobutyrate into the eyes of three rabbits resulted in mild transient conjunctival erythema which resolved within 24 hours. Instillation of a 5% dilution of Linalyl Isobutyrate resulted in mild transient conjunctival erythema which resolved within 1 hour. Undiluted Linalyl Isobutyrate was found to be a minimal eye irritant under the conditions of this study and does not require classification as an eye irritant according to the CLP Regulation. While iris effects were not specifically assessed in this study, no effects of treatment were observed on pupil reaction. This deviation from the guideline is not considered to be critical.