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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

Data source

Reference
Reference Type:
publication
Title:
Final Amended Report on the Safety Assessment of Methylparaben, Ethylparaben, Propylparaben, Isopropylparaben, Butylparaben, Isobutylparaben, and Benzylparaben as used in Cosmetic Products
Author:
Cosmetic Ingredient Review Expert Panel.
Year:
2008
Bibliographic source:
International Journal of Toxicology,Vol 27, Issue 4_suppl, pp. 1 - 82, 2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
The tset was performed on eyes of rabbits
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzyl 4-hydroxybenzoate
EC Number:
202-311-9
EC Name:
Benzyl 4-hydroxybenzoate
Cas Number:
94-18-8
Molecular formula:
C14H12O3
IUPAC Name:
benzyl 4-hydroxybenzoate
Details on test material:
- Name of test material (as cited in study report): Benzylparaben (Synonyms of Benzoic acid, 4-hydroxy-, phenyl methyl ester)
- Molecular formula (if other than submission substance): C14-H12-O3
- Molecular weight (if other than submission substance): 228.2458 g/mol
- Substance type: Organic
- Physical state: Solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Details on test animal
TEST ANIMALS
- Source: No data available
- Age at study initiation: No data available
- Weight at study initiation: No data available
- Fasting period before study: 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

Or Test Tissue
- Source: No data available
- Type: No data available
- Acclimation : No data available
- Housing conditions: 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

IN-LIFE DATES: From: To: No data available

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
0.1g
Duration of treatment / exposure:
No data available
Observation period (in vivo):
1,24,48 or 72 hrs
Number of animals or in vitro replicates:
3
Details on study design:
No data available

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Reversibility:
not specified
Remarks on result:
other: other details not known
Irritant / corrosive response data:
non-irritating to eyes
Other effects:
No data available

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The benzylparaben (94-18-8) was found to be non-irritating to eyes of rabbits.
Executive summary:

The eye irritation test was performed on 3 New Zealand rabbits treated with 0.1g of benzylparaben was applied to the conjunctival sac. No adverse effect was observed at 1, 24, 48 and 72 hrs of observation.

Therefore, benzylparaben (94-18-8) was found to be non-irritating to eyes of rabbits.