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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:
other: as mentioned below
Principles of method if other than guideline:
The ocular irritation study of test chemical was conducted on rabbits to assess the irritation potential of test chemical.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
-Name of the test material : benzyl formate
-Substance type : Organic
-Physical state : colorless liquid
- Molecular formula: C8H8O2
- Molecular weight : 136.14792 g/mol
- Smiles notation: C1=CC=C(C=C1)COC=O
- Purity : No data available
- Impurities (identity and concentrations): No data available

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:No Data Available
- Age at study initiation: No Data Available:
- Weight at study initiation:No Data Available
- Housing:No Data Available
- Diet (e.g. ad libitum):No Data Available
- Water (e.g. ad libitum):No Data Available
- Acclimation period:No Data Available

ENVIRONMENTAL CONDITIONS
- Temperature (°C):No Data Available
- Humidity (%):No Data Available
- Air changes (per hr):No Data Available
- Photoperiod (hrs dark / hrs light):No Data Available

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.1 ml (undiluted)
Duration of treatment / exposure:
1, 48, 72 h and 7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
four female SPF alibino rabbits
Details on study design:
Not specified

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 days
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
At 24 h after dosing, corneal opacity was scattered or diffuse on more than one quarter but less than one half of the cornea.
Other effects:
no data

Any other information on results incl. tables

No signs of eye irritation were observed in rabbit using 0.1 ml of undiluted test material.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
Since the observed effects were cleared within the observation period of 7 days, the test chemical was considered as not irritating to the eyes of treated rabbits.
Executive summary:

The ocular irritation study of test chemical was conducted in four female SPF albino rabbits to assess the irritation potential of test chemical.

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 conjunctiva were still diffuse, crimson red with individual vessels not easily discernible, swelling was still 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 still diffusely red; the individual vessels were not easily discernible and abnormal swelling still present.

At 72 h after dosing, the conjunctival vessels were still 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. Since the observed effects were cleared within the observation period of 7 days, the test chemical was considered as not irritating to the eyes of treated rabbits.