1,4-bis(butylamino)anthraquinone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: early study, no GLP; short report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Remarks:

pre-dates GLP regulation

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,4-bis(butylamino)anthraquinone

EC Number:

241-379-4

EC Name:

1,4-bis(butylamino)anthraquinone

Cas Number:

17354-14-2

Molecular formula:

C22H26N2O2

IUPAC Name:

1,4-bis(butylamino)anthraquinone

Details on test material:

technically pure

Test animals

Species:

rabbit

Strain:

other: white Wiener

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: BASF, Ludwigshafen, Germany
- Age at study initiation: no data
- Weight at study initiation: ca. 2,8 kg (mean)


- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

olive oil

Details on dermal exposure:

TEST SITE
- Area of exposure: 340 cm²
- Type of wrap if used: paper and textile

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration: 30 % (paste)
- Constant concentration used: yes
- For solids, paste formed: yes

VEHICLE
Olive oil
- Amount(s) applied (volume): ca 4 mL in treated and 8-9 mL in control

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

male treaded: 4
female treaded: 2
male untreaded: 1
female untreaded: 1

Control animals:

yes, concurrent vehicle

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs; other: local irritation effects

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

approximate LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

1 male animal died 10 days after treatment.

Clinical signs:

other: Temporary diarrhea, severe local blue discoloration by the test material. One male showed reduced food uptake and degraded general condition before it died after 10 days. No findings in control animals.

Gross pathology:

Moderately reduced to completely missing perirenal fatty tissue.
In one animal perirenal fatty tissue was well developed with blue discoloration.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The aproximate lethal dose was above 2000 mg/kg bw in rabbits after dermal application for 24 hours.

Executive summary:

The acute dermal toxicity of the test material was determined in six rabbits. The material was applied at a dose os 2000 mg/kg bw (limit test) at a concentration of 30 % in olive oil und semiocclusive conditions for 24 hours. Animals developed temporary diarrhea and severe blue discoloration by the test material on the first day. One male animal died after ten days after showing reduced general condition and food uptake.

Controls did not show any effects.

The aproximate lethal dose was above 2000 mg/kg bw in rabbits after dermal application for 24 hours.