Polysulfides, di-tert-dodecyl

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

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

Reference substance name:

Polysulfides, di-tert-dodecyl

EC Number:

270-335-7

EC Name:

Polysulfides, di-tert-dodecyl

Cas Number:

68425-15-0

Molecular formula:

not applicable

IUPAC Name:

di (alkyl C11-C13 Branched, C12 Rich), polysulfure S3-S5 rich

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IFFA-CREDO, France
- Age at study initiation: 5-7 weeks old
- Mean weight at study initiation: 189-192g for males and 164-166g for females
- Housing: individual housing in stainless steel mesh cages
- Diet (ad libitum): Rat pelleted complete maintenance (UAR, France)
- Water (ad libitum): softened and filtered drinking water
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back
- % coverage: 10%
- Type of wrap if used: wide aghesive and perforated tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with lukewarm water
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml/kg

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

other: yes, distillated water

Details on study design:

- Duration of observation period following administration: 14 days
- Clinical signs ans skin reactions: 15 min after administration, then 1, 2 and 4 hours and daily for 14 days
- Body weight: day -1, 1, 8 and 15
- Necropsy of survivors performed: yes

Statistics:

Not appropriate

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: No mortality and no behavioral anomalies were noted following the administration of the product and during the 14 following days. The local tolerance of the product was good: no cutaneous lesions (erythema or oedema) were observed at the site of product a

Gross pathology:

No macroscopic abnormality was observed in the animals sacrificed at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The dermal LD0 of TPS 32 is higher than 2000 mg/kg.

Executive summary:

In an OECD TG 402 study, Sprague-Dawley rats (n=20; male and female) were dermally exposed to di-t-dodecyl polysulfides (TPS 32). No mortality or behavioral abnormalities were noted following the initial administration of the test substance or during the 14 days following exposure. No cutaneous lesions were observed at the site of application or during the observation period. Body weight gain was not affected by the treatment, and no macroscopic abnormalities were observed in the animals sacrificed at the end of the observation period. The dermal LD₀was > 2000 mg/kg bw.