Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
low test concentration

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975
Reference Type:
publication
Title:
Assessment of the acute toxicity and potential irritancy of hair dye constituents
Author:
Lloyd G.K., Ligget M.P., Kynoch S.R. and Davies R.E.
Year:
1977
Bibliographic source:
Food and Chemical Toxicity, 15, 607- 610

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: procedure was based on the Consumer Product Safety Commission of the USA (Code of Federal Regulation, Title 16, Sec. 1500.41)
- Short description of test conditions: An solution of 2.5% solution of naphthol was evaluated in New Zealand White rabbits, this application was made to the intact and abraded skin
- Parameters analysed / observed: Primary Irritant Code


GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
No data
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: No data
- Expiration date of the lot/batch: No data
- Purity test date: No data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: No data
- Stability under test conditions: No data
- Solubility and stability of the test substance in the solvent/vehicle: No data
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: No data

TREATMENT OF TEST MATERIAL PRIOR TO TESTING No

FORM AS APPLIED IN THE TEST: Suspension

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

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

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
other: Gum Tragacanth
Remarks:
Kipton Bros, London, Grade 1, BP
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 2.5 % w/v

VEHICLE
- Amount(s) applied (volume or weight with unit): No data
- Concentration (if solution): 0.5%
- Lot/batch no. (if required): No data
- Purity: No data
Duration of treatment / exposure:
24 hours
Observation period:
72 hours (24 hours treatment and 48 hours observation)
Number of animals:
3 (intact skin) and 3 (abraded skin)
Details on study design:
TEST SITE
- Area of exposure:
- % coverage: No data
- Type of wrap if used: surgical gauz and the entire trunk of the animal is wrapped with an impervious material such as rubberized cloth (to maintain the test patches and retards the evaporation)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: 24 hours

OBSERVATION TIME POINTS : 24 and 72 hours

SCORING SYSTEM: Primary irritation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
72 h
Score:
ca. 0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24 h
Score:
ca. 0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
One of the animals showed any observable response to treatment throughout the 72 hours observation period.
There was no other reaction observed at 24 hours or 72 hours later.
Other effects:
- Other adverse local effects: No data
- Other adverse systemic effects: No data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Note: harmonized classification as Skin Irr 2
Conclusions:
Under the conditions of the experiment, a 2.5% aqueous suspension of 1-naphthol was considered not to be irritant to rabbit skin.
Executive summary:

The skin irritation potential of 1-naphthol was evaluated in New Zealand White rabbits. Application of a 2.5% solution in aqueous gum tragacanth was made to the intact and abraded skin. The period of application was not stated. There was no reaction observed at 24 hours or 72 hours later.