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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Submission of unpublished data by CTFA. Rabbit eye irritation study.
Author:
CLAIROL
Year:
1979
Bibliographic source:
(Cited by CIR, 1991)

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: The use of secondary sources of data is acceptable when they are based in a critical evaluation of peer-reviewed data and a consequent selection of a reliable and representative value for the property under investigation. The data were collected and reviewed by CIR in a safety assessment of a cosmetic ingredient. Therefore, although the method used is not known, the values presented here are acceptable as they are from a reliable secondary source of toxicological information. The tested substance is applied in a single dose to one of the eyes of the experimental animal; the untreated eye serves as the controlthe degree of eye irritation/corrosion is evaluated by scoring lesions. The duration of the study should be sufficient to evaluate the reversibility or irreversibility of the effects.
- Short description of test conditions: The ocular irritation of pyrogallol was evaluated in rabbits (six/group) after a single exposure; Pyrogallol was applied as powder.
- Parameters analysed / observed: irritation effects were observed.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Test material form:
not specified
Details on test material:
not specified
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: not specified
- Expiration date of the lot/batch: not specified
- Purity test date: not specified

RADIOLABELLING INFORMATION (if applicable) not applicable
- Radiochemical purity: -
- Specific activity: -
- Locations of the label: -
- Expiration date of radiochemical substance: -

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not specified
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: not specified
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not specified

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not specified
- Preliminary purification step (if any): not specified
- Final dilution of a dissolved solid, stock liquid or gel: not relevant: the substance was applied as a powder
- Final preparation of a solid: applied as such

FORM AS APPLIED IN THE TEST (if different from that of starting material) : solid (powder)

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable) not applicable

OTHER SPECIFICS: no other specifics available

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: weight 2.5-3.0 kg
- Housing: not specified
- Diet (e.g. ad libitum): not specified
- Water (e.g. ad libitum): not specified
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not specified
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): not specified

IN-LIFE DATES: From: To: not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 1% solution of Pyrogallol (in propylene glycol)

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 1% solution of Pyrogallol (in propylene glycol)
- Lot/batch no. (if required): -
- Purity: -
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
not specified
Duration of post- treatment incubation (in vitro):
not specified
Number of animals or in vitro replicates:
6 (males)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: not specified
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
other: overall
Time point:
other: not specified
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
other: overall
Time point:
other: nor specified
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
other: overall
Time point:
other: not specified
Reversibility:
not specified
Remarks on result:
not measured/tested
Irritant / corrosive response data:
the 1% solution of Pyrogallol was not an ocular irritant.
Other effects:
no other effects were reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Pyrogallol in solution was not irritant.
Executive summary:

The ocular irritation of the chemical was evaluated in male New Zealand White rabbits (six/group). Pyrogallol was applied as 1% solution of the substance in propylene glycol, into the conjunctival sac.

The eyes were not rinsed after instillation in either treatment group. Untreated eyes served as controls.

Pyrogallol does not induced ocular irritation.