Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-785-7 | CAS number: 99-76-3
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:
- 1 976
- 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:
- 2 006
- 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
- 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
- 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%
Constituent 1
Constituent 2
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 which was fully reversible within 48 h.
- 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. This effect was fully reversible within 48 h.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
