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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from peer reviewed publication.

Data source

Reference
Reference Type:
publication
Title:
Guinea Pig Maximization Test for Trichloroethylene and Its Metabolites
Author:
TANG XIAO-JIANG, LI LAI-YU, HUANG JIAN-XUN, AND DENG YING-YU
Year:
2002
Bibliographic source:
BIOMEDICAL AND ENVIRONMENTAL SCIENCES 15, 113-118 (2002)

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Primary Irritation Study had been performed as part of Guniea Pig Maximixation Test (GPMT) for evaluating contact allergenic activity of Chloral hydrate in Albino guinea pigs.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material: 2,2,2-Trichloroethane-1,1-diol (Chloral hydrate)
- Molecular formula: C2-H3-Cl3-O2
- Molecular weight: 165.4026g/mol
- Smiles notation: C(C(O)O)(Cl)(Cl)Cl
- InChl: RNFNDJAIBTYOQL-UHFFFAOYSA-N
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material: 2,2,2-Trichloroethane-1,1-diol (Chloral hydrate)
- Molecular formula: C2-H3-Cl3-O2
- Molecular weight: 165.4026g/mol
- Smiles notation: C(C(O)O)(Cl)(Cl)Cl
- InChl: RNFNDJAIBTYOQL-UHFFFAOYSA-N
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
guinea pig
Strain:
other: FMMU strain
Details on test animals and environmental conditions:
- Source: Medical laboratory animal center (China).
- Age at study initiation: No data available
- Weight at study initiation: 300-350g
- Housing: Housed in an animal rooms.
- Diet (e.g. ad libitum): Standard guinea pig diet and Fresh vegetable
- Water (e.g. ad libitum): Tap water
- Acclimation period: One week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23°C±1.5 °C
- Humidity (%): 55% ±10%
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 12 h day/night cycle

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

Test system

Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
other: distilled water
Controls:
yes
Amount / concentration applied:
Induction: Intradermal concentration: 1%
Topical concentration: 5%

Challenge topical concentration : 2%
Duration of treatment / exposure:
24 hrs
Observation period:
not specified
Number of animals:
4
Details on study design:
- Area of exposure: back of animals
- % coverage: 4cm x 6 cm
- Type of wrap if used: not specified

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified
- Time after start of exposure: not specified

SCORING SYSTEM: not specified

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
animal: induction exposure animals
Time point:
24 h
Reversibility:
not reversible
Remarks on result:
positive indication of irritation
Remarks:
moderate erythma
Irritant / corrosive response data:
moderate erythma at two induction concentrations
Other effects:
not specified

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Chloral hydrate induced moderate erythma at two induction concentrations of 1 and 5% in primary Irritation study.
Executive summary:

Primary Irritation Study had been performed as part of Guniea Pig Maximixation Test (GPMT) for evaluating contact allergenic activity of Chloral hydrate in Albino guinea pigs. An area of 4cm x 6 cm on the back of animals were clipped free of hair. 24 h later, the intact animals were selected in the test. The moderate irritant concentration of 1% and 5% for intrademal and topical induction application respectively, and the non-irritant concentration of 2% for challenge were established in guinea pigs. The vehicle used was distilled water. Chloral hydrate was observed to induce moderate erythma at two induction concentrations of 1 and 5% but the challenge topical concentration did not induce any abnormal appearance in primary Irritation study.

Thus on the above result the test substance Chloral hydrate is considered to be moderately irritating to skin and hence can be classified as Skin Irritant 2 as per CLP classification criteria.