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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 November 1986 - 30 December 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was not performed under GLP. OECD 402 was followed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Chemical name: Disodium tetrasulphide (natriumtetrasulfid)
Appearance: Ocherous solid
Batch number: Na2S4-1

No CoA inlcuded in the study, no information on purity and composition of the test substance. For additional information see attached document.
In the results section of the report the test substance is described as a dark red solid. In the test substance information the test substance is described as an ocherous solid.

Test animals

Species:
rabbit
Strain:
other: Weisse Russen (albino)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Asta-Werke AG, D-4800 Bielefeld 14
- Age at study initiation: Males 15 - 28 weeks, females 15-21 weeks
- Weight at study initiation: Males 1.88 - 2.27 kg, females 1.86 - 2.32 kg
- Fasting period before study: On the day of application food was withheld.
- Housing: steel cages, bar floor, model asta. One animal per cage.
- Diet (e.g. ad libitum): Ad libitum, standard food for rabbits, ssniff(K).
- Water (e.g. ad libitum): Ad libitum.
- Acclimation period: minimal 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 26 November 1986 - 30 December 1986

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: between the shoulder and hipbone
- % coverage: no data
- Type of wrap if used: occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 24 hours the skinned was whiped clean with water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1 g test substance per 0.5 ml water
- Concentration (if solution): 2g/ml
- Constant volume or concentration used: yes
- For solids, paste formed: yes


Duration of exposure:
24 hours
Doses:
200, 633, 2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 6-8 hours after the apllication of the test substance. After the first days animals were observed daily. Time of death and number of animals are recorded. Check for mortality was performed twice daily duringw eek days and once a day in the weekend. Clinical signs and severity, time of onset and duration are recorded.
Bodyweights are determined immediatly after dosing after 7 days and after 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: None
Statistics:
Graphic average separate for males and females.

Results and discussion

Preliminary study:
Not applicable
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
590 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
1 650 mg/kg bw
Mortality:
In the male 2000 mg/kg dose group 2 out of 3 animals died. 1: 2 hours after application and 1: 24 hours after application. In the female 2000 mg/kg bw group 3 out of 3 animals died. 1: 0.5 hours after applicationa and 2: 1 hour after application. In the female 633 mg/kg bw group 2 out of 3 animals died. 1: 1 hours after application and 1: 2 hours after application.
Clinical signs:
General bad appearance, cyanosis, labored breathing. Before death general reflex loss was observed. In the female animals vocalisation, red foam from the mouth and nose was observed.
First symptoms were observed 40 minutes after application of the test substance and remained for 3 days. A dosis of 200 mg/kg did not lead to any clinical signs.
The skin of all animals showed scabs after removal of the test substance at 24 hours.
Body weight:
No effects observed.
Gross pathology:
In the animals that died during the study the lungs were colored dark red and in the high dose group 2 animals showed balckening of the lungs.
The animals that were sacrificed at the end of the study showed no abnormalities. Form one of the animals the lungs were investigated more closely and acute hyperaemia with moderate intaaveolair oedema was observed.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The LD50 in female animals was estimated at 590 mg/kg bw. The LD50 for males was estimated at 1650 mg/kg bw.
Executive summary:

For the determination of the acute dermal toxicity disodium tetrasulphide was applied to the skin on the back of 3 groups of male and female rabbits (3/dose/sex). Doses were 200, 633, 2000 mg/kg bw. The animals were exposed for 24 hours and under occlusion. The study was performed according to OECD 402. In the male 2000 mg/kg dose group 2 out of 3 animals died. 1: 2 hours after application and 1: 24 hours after application. In the female 2000 mg/kg bw group 3 out of 3 animals died. 1: 0.5 hours after applicationa and 2: 1 hour after application. In the female 633 mg/kg bw group 2 out of 3 animals died. 1: 1 hours after application and 1: 2 hours after application. General bad appearance, cyanosis, labored breathing. Before death general reflex loss was observed. In the female animals vocalisation, red foam from the mouth and nose was observed. First symptoms were observed 40 minutes after application of the test substance and remained for 3 days. A dosis of 200 mg/kg did not lead to any clinical signs. The skin of all animals showed scabs after removal of the test substance at 24 hours. In the animals that died during the study the lungs were colored dark red and in the high dose group 2 animals showed blackening of the lungs. The animals that were sacrificed at the end of the study showed no abnormalities. Form one of the animals the lungs were investigated more closely and acute hyperaemia with moderate intraveolair oedema was observed. The LD50 in female animals was estimated at 590 mg/kg bw. The LD50 for males was estimated at 1650 mg/kg bw.