Registration Dossier

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:
other: GLP 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:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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:
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 application or during the observation period
Body weight:
The body weight gain of the treated animals was not affected by the treatment.
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.