Formaldehyde, reaction products with 5,12-dihydroquino[2,3-b]acridine-7,14-dione and 3,5-dimethyl-1H-pyrazole, sulfonated

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991-12-11 to 1992-02-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline Study (OECD 402)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

other: Tif: RAI f (SPF),

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production; 4332 Stein / Switzerland;
- Initial body weight range: 227 to 275 g
- Husbandry :The rats were kept in an animal room under conventional laboratory conditions
- Photoperiod: 12 hour/day light cycle.
- Air changes: approximately 15 air changes per hour
- Temperature: 22 +/- 2 °C
- Humidity: 55 +/- 10 %
- Housing: The rats were individually housed in Macrolon cages type 3, with standardized soft wood bedding
- Acclimation: Rats were acclimatized for at least 5 days before exposure.
- Diet and water: Diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland) and water were provided ad libitum.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80

Details on dermal exposure:

TEST SITE
- Area: Approximately 24 hours before treatment an area on the back of the rat of at least 10 % of the body surface was shaved with an electric clipper.
- The test substance suspension was evenly dispersed on the skin.
- Coverage: It was covered with a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage.

TEST MATERIAL
- Amount applied: 4 ml tetst item formulation/kg bw (containing 2 g test item)

REMOVAL OF TEST SUBSTANCE
- Washing: After an exposure period of 24 hours the dressing was removed and the skin was cleaned with lukewarm water.
- Thereafter the skin reaction was appraised repeatedly.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males/5 females

Control animals:

not required

Details on study design:

- Observation period: 14 days
- Frequency of observations and weighing:
Mortality: daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms: daily for 14 days
Weighing: on day 0, 7, and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Piloerection, slight erythema (caution: test substance is red coloured)

Gross pathology:

No observable abnormalities

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU