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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 8, 1990 - January 29, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline 402 study, GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetra-sodium/lithium 4,4'-bis-(8-amino-3,6-disulfonato-1-naphthol-2-ylazo)-3-methylazobenzene
EC Number:
408-210-8
EC Name:
Tetra-sodium/lithium 4,4'-bis-(8-amino-3,6-disulfonato-1-naphthol-2-ylazo)-3-methylazobenzene
Cas Number:
124605-82-9
Molecular formula:
C33 H26 N8 O14 S4 .x Li .x Na
IUPAC Name:
tetra-sodium/lithium 4,4'-bis-(8-amino-3,6-disulfonato-1-naphthol-2-ylazo)-2-methylazobenzene
Details on test material:
- Physical state: powder
- Stability under test conditions: stable for at least 2 hours

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., CH-4414 Fuellinsdorf
- Age at study initiation: males: 10 weeks, females: 12 weeks
- Weight at study initiation: males: 201 - 239 g, females: 183 - 197 g.
- Housing: Groups of five in Makrolon type-3 cages with standard softwood bedding
- Diet: Pelleted standard Kliba 343, Batch 61/89 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst) available ad libitum.
- Water: Community tap water from Itingen, available ad libitum.
- Acclimation period: One week under laboratory conditions, after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3 °C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark, music/light period

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: bi-distilled water
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- % coverage: 10%
- Type of wrap if used: covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with lukewarm tap water, dried with disposable paper towels
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml/kg body weight
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations: Four times during test day 1, and daily during days 2 - 15.
- Frequency of observations: Test days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
The LOGIT-Model could not be applied to the observed rate of death. The toxicity was estimated without use of a statistical model.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
No systemic symptoms were observed.
The following local signs were observed: males/females - scales (Back), blue skin (Back). Males had recovered after 11 observation days (scales) except blue skin which was observed till termination of test. Females showed scales and blue skin until termination of test.
Body weight:
The body weight gain of three females was partly affected by test article treatment: One animal showed loss of weight throughout the entire study and two animals showed loss of weight between day 1 to 8 of observation. The body weight of the other animals was not affected throughout the entire study.
males (mean): 222,2 g / 247,7 g / 267,6 g (days 1/8/15).
females (mean): 192,0 g / 192,2 g / 194,5 g (days 1/8/15).
Gross pathology:
Lungs: Discoloration dark red (1 animal).

Applicant's summary and conclusion

Conclusions:
The acute dermal toxicity of the test substance in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg bw.
Executive summary:

In a dermal acute toxicity study according to OECD guideline 402, five male and five female rats were treated semiocclusively with the test article in bi-distilled water for 24 hours and observed for 15 days. There were no deaths. Male animals showed scales until day 11 on the back and blue skin until termination of test. Females showed scales and blue skin until termination of test. No systemic symptoms were observed. The body weight of three animals was partly affected by test article treatment: One animal showed loss of weight throughout the entire study, two additional animals showed loss of weight between day 1 to 8 of observation. At necropsy, discolored lungs (dark red) were observed in one animal. Under the conditions of this study, the LD50 is greater than 2000 mg/kg body weight in male and female rats when topically applied.