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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed journal

Data source

Reference
Reference Type:
publication
Title:
Fragrance material review on Benzyl formate
Author:
D. McGinty; C.S. Letizia; A.M. Api
Year:
2012
Bibliographic source:
Food and Chemical Toxicology, 50 (2012) S402-S406.

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To evaluate the eye irritation potential of benzyl formate on SPF albino rabbits
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Benzyl formate
Cas Number:
104-57-4
Molecular formula:
C8H8O2
IUPAC Name:
Benzyl formate
Details on test material:
IUPAC: Benzyl formate
Molecular formula :C8H8O2
Molecular weight :136.15 g/mol
Substance type:organic
InChI:1S/C8H8O2/c9-7-10-6-8-4-2-1-3-5-8/h1-5,7H,6H2
Smiles :c1(ccccc1)COC=O
Specific details on test material used for the study:
IUPAC: Benzyl formate
Molecular formula :C8H8O2
Molecular weight :136.15 g/mol
Substance type:organic
InChI:1S/C8H8O2/c9-7-10-6-8-4-2-1-3-5-8/h1-5,7H,6H2
Smiles :c1(ccccc1)COC=O

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF albino rabbits
Details on test animals or tissues and environmental conditions:
4 animals were used

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye of each animal served as a control.
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
No data available
Observation period (in vivo):
1, 48, 72 h and 7 days
Details on study design:
Application of fluorescein was used for the confirmation of findings.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
7 d
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
ocular reactions were observed by 24 , 48 , 72 hrs after installation of test substance, which was reversible by day 7
Other effects:
At 24 h after dosing, corneal opacity was scattered or diffuse on more than one quarter but less than one half of the cornea.
The conjunctiva were diffuse, crimson red with individual vessels not easily discernible, swelling was noted as well as an abnormal
discharge.
At 48 h after dosing, the scattered or diffuse area of opacity was noted on one quarter or less of the cornea, even after instillation of fluorescein

Applicant's summary and conclusion

Interpretation of results:
other: Not eye irritant
Conclusions:
Benzyl formate when applied on the eye of SPF albino rabbits and observed for 7 days gave ocular reactions which were cleared by day 7. Hence , Benzyl formate is considered to be non eye irritant.
Executive summary:

Benzyl formate (undiluted) was evaluated for eye irritation in four female SPF alibino rabbits. A dose volume of 0.1 ml was instilled into one eye. The untreated eye of each animal served as a control. Observations were made at 1, 48, 72 h and 7 days after treatment. At 24 h after dosing, corneal opacity was scattered or diffuse on more than one quarter but less than one half of the cornea. Application of fluorescein confirmed this finding. The conjunctivawere diffuse, crimson red with individual vessels not easily discernible, swelling was noted as well as an abnormal discharge. At 48 h after dosing, the scattered or diffuse area of opacity was still noted on one quarter or less of the cornea, even after instillation of fluorescein. The conjunctiva was diffusely red; the individual vessels were not easily discernible and abnormal swelling was present. At 72 h after dosing, the conjunctival vessels were injected and following the instillation of fluorescein a scattered or diffuse area of opacity on one quarter or less of the cornea was noted. By 7 days after dosing the animals were free of any signs of eye irritation

 Benzyl formate when applied on the eye of SPF albino rabbits and observed for 7 days gave ocular reactions which were cleared by day 7. Hence , Benzyl formate is considered to be non eye irritant.