Sodium 3-[(1,5-dihydroxy-2-naphthyl)azo]-4-hydroxybenzenesulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1999-2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Name: Diamantechtrot BT

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HARLAN WINKELMANN, Gartenstr. 27, 33178 Borchen, Germany, SPF breeding colony
- Age at study initiation: 6 - 10 weeks
- Weight at study initiation:
male animals: mean = 265 g (= 100 %)
s = ±27 g
min = 240 g (- 9.4 %)
max = 309 g (+16.6 %)
n = 5
female animals: mean = 219 g (= 100 %)
s = ± 14 g
min = 200 g (- 8.7 %)
max = 231 g (+ 14.2 %)
n = 5
- Fasting period before study: no
- Housing: macrolon cages (type 3) on soft wood granulate, one animal per cage
- Diet (e.g. ad libitum): ssnif R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±3°C
- Humidity (%): 50 ±20 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: September 15, 1999 to September 29, 1999:

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Remarks:

deionized

Details on dermal exposure:

Before dermal treatment the fur was mechanically removed from the dorsal skin of the animals over an area of approximately 30 cm²

0.5 g Diamantechtrot BT was moistened with 0.4 ml deionized water.

The appropriate amount of the test substance was moistened on a two-ply gauze and an aluminium foil (6 x 8 cm) and distributed as uniformly as possible. Together with the foil the test substance was administered to the shaved and intact dorsal skin. The foil was held in place with an elastic plaster bandage fixed around the animal's body (Fixomull and Elastoplast, 8 cm in width, both manufactured by Beiersdorf Aktiengesellschaft).
At the end of the dermal exposure period of 24 hours the bandage was removed and the treated skin area washed with warm water in order to remove any unabsorbed remnants of the test substance.
The observation period after the dermal administration lasted for 14 days. Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends and public holidays only once.
During this time the animals were weighed weekly. At the end of the observation period the animals were killed by carbon dioxide
asphyxiation, dissected and examined for macroscopically visible changes.

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes/no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occurred during the whole study.

Clinical signs:

other: No clinical signs

Gross pathology:

The animals killed at the end of the observation period showed no macroscopically visible changes.

Other findings:

The skin of the animals was sporadically discoloured reddish in a large area.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results obtained in this study the median lethal dose value (LD50) of Diamantechtrot BT for male and female rats is greater than 2000 mg/kg body weight.

Executive summary:

Acute dermal toxicity testing of Diamantechtrot BT in the rat yielded a median lethal dose (LD50) above 2000 mg/kg body weight in both male and female animals.

After administration of 2000 mg/kg b.w. neither deaths nor symptoms occurred.

From day 2 up to day 7 of the study the treated skin of the female animals was sporadically discolored reddisch in a large area.

One male and three female animals showed disturbance of body weight gain during the first week of the study. Up to the end of the study (day 15) the body weight gain returned to normal.

The animals killed at the end of the observation period showed no macroscopically visible changes.