3-(2-hydroxyethyl)-p-phenylenediammonium sulphate

Skin irritation / corrosion

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:

A read-across with the analogue substance 2-(2,5-diaminophenyl)ethanol dihydrochloride is proposed. The substance detailed in section 1 and the analogue material are both salts of 2-(2,5-diaminophenyl)ethanol with similar physical and chemical properties.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Determination of the local compatibility of the test substance by repeated open-epicutaneous application to the albino guinea pig following the method according to Draize. 3% dilution of 1-beta-hydroxyethyl-2,5-diaminobenzene dihydrochloride in 0.5% aqueous tylose was applied onto the clipped flank region of 15 albino Guinea pigs for 5 consecutive days.. The skin was not covered but animals were restrained from movement during the first 5 hours. Possible skin reactions were evaluated for erythema and oedema 5 hours after each application.

GLP compliance:

no

Test material

Test material information

1

Reference substance name:

1-Beta-hydroxyethyl-2,5-diaminobenzene dihydrochloride

Molecular formula:

C8H12N2O.2HCl

IUPAC Name:

1-Beta-hydroxyethyl-2,5-diaminobenzene dihydrochloride

Test animals

Species:

guinea pig

Strain:

other: White Pirbright (SPF)

Test system

Type of coverage:

open

Preparation of test site:

clipped

Vehicle:

other: 0.5% aqueous tylose

Controls:

no

Amount / concentration applied:

3% dissolved in 0.5% aqueous tylose

Duration of treatment / exposure:

Five days

Observation period:

Five hours after each application

Number of animals:

Fifteen females

Details on study design:

The test substance was open-epicutaneously applied to the clipped (Elektra II GH204 hair clipper fitted with 1/20 clipper head, Aeskulap Inc.) flank skin (3 x 4cm) of the alino guinea pigs following the method according to Draize.

Application : The test substance was applied daily using a brush and was not removed by washing. The assessment of the skin reactions was performed daily five hours after the application. The overall exposure duration was 5 days.

Analysis : The following criteria were considered in the evaluation of the skin reactions after each treatment and during the observation period ; 1) erythema and eschar formation, 2) oedema formation, 3) behaviour and general conditions of the animals.

Determination of the results : The skin reactions were determined by two persons independently of each other and the mead calculated. The assessment of the skin reactions was conducted according to the scoring system of Draize.

Animal husbandry : The guinea pigs were fixed in individual boxes during the treatment phase so that contact with the treated flank either by themselves or by other animals was impossible. During the following observation period, the animals were kept in wire cages. All animals received a standard laboratory diet and drinking water ad libitum.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No erythematous skin reactions were noticed during the entire observation period. Other symptoms of inflammation such as oedema were not observed. Necrosis or wheals did not occur. The 3% solution of the test substance is clasified as not irritating.

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Conclusions:

No indication of a skin irritating potential of 1-beta-hydroxyethyl-2,5-diaminobenzene dihydrochloride tested at a 3% aqueous solution in a repeated application assay in Guinea pigs was noted.