Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to Eye irritation test design (modified Draize), but not according to OECD Guideline.

Data source

Referenceopen allclose all

Reference Type:
other: CIR study summary
Title:
Unnamed
Year:
1976
Report date:
1976
Reference Type:
review article or handbook
Title:
Final Report of the Cosmetic Ingredient Review expert Panel: Amended Safety Assessment of Methylparaben, Ethylparaben, Propylparaben, isopropylparaben, and Benzylparaben
Author:
Bergfeld, W. F. et al.
Year:
2006
Bibliographic source:
Cosmetic Ingredient Review, Washington, US, 1-86, 2006.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Eye irritation test design (modified Draize).
Examinations for injuries or irritation will be made until all eyes are negative or for seven days, whichever occurs first.
GLP compliance:
no
Remarks:
study performed before GLP Guidelines

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl 4-hydroxybenzoate
EC Number:
202-785-7
EC Name:
Methyl 4-hydroxybenzoate
Cas Number:
99-76-3
Molecular formula:
C8H8O3
IUPAC Name:
methyl 4-hydroxybenzoate
Constituent 2
Reference substance name:
Methylparaben
IUPAC Name:
Methylparaben
Details on test material:
- Name of test material (as cited in study report): Methylparaben 0410
- Product type: per se
- Concentration: 100%
- Concentration tested: 100%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Specie: Albino rabbit/New Zealand
- Sex: males and/or females
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Photoperiod (hrs dark / hrs light): no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Frequency: once
- Product type: per se
- Concentration tested: 100%

VEHICLE: none
Duration of treatment / exposure:
no data
Observation period (in vivo):
48 hours
Number of animals or in vitro replicates:
6
Details on study design:
METHODS:
Six healthy albino rabbits, males and/or females, were used.
The test material was instilled into one eye of each animal; the other eye served as the control.

OBSERVATIONS:
Examinations for injuries were made at 24, 48, and 72 hours and at four and seven days.
Observations of injuries or irritation resulting from contact with these substances were made on the cornea, iris, and conjunctiva.
Eye irritation was graded and scored according to the scoring system of Draize, J. H., from the Appraisal of the Safety of Chemicals in Foods, drugs, and Cosmetics, association of Food and Druf Officials of the U.S., Austin, Texas, 1959.
Maximum score = 110

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Day 1
Score:
1
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Day 2
Score:
0
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: mean score on cornea opacity, iris, chemosis and conjunctivae
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: mean score on cornea opacity, iris, chemosis and conjunctivae
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: mean score on cornea opacity, iris, chemosis and conjunctivae
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: mean score on cornea opacity, iris, chemosis and conjunctivae
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: mean score on cornea opacity, iris, chemosis and conjunctivae
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: mean score on cornea opacity, iris, chemosis and conjunctivae
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: mean score on cornea opacity, iris, chemosis and conjunctivae
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: mean score on cornea opacity, iris, chemosis and conjunctivae
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: mean score on cornea opacity, iris, chemosis and conjunctivae
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: mean score on cornea opacity, iris, chemosis and conjunctivae
Irritation parameter:
chemosis score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: mean score on cornea opacity, iris, chemosis and conjunctivae
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: mean score on cornea opacity, iris, chemosis and conjunctivae

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Methylparaben produced slight transient irritation with an eye irritation score of 1/110 on Day 1 when applied to the eyes of rabbits.
Executive summary:

Methylparaben produced slight transient irritation with an eye irritation score of 1/110 on Day 1 when applied to the eyes of rabbits.