Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 June - 9 July 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(1981)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Date of Inspection 17 March 1992
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): PEMP (2,2-Dimethylpropanetatryl tetrakis (3-mercaptopropionate))
- Substance type: Organic
- Physical state: Pale yellow clear liquid with sulfur odor
- Storage condition of test material: Room temperature under nitrogen, shielded from light
- No information on purity
Specific details on test material used for the study:
The test was performed with PEMP product, the registered substance.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, U.K.
- Age at study initiation: appr. 10-14 weeks
- Weight at study initiation: 230-241g (males); 209-227g (females)
- Fasting period before study: No
- Housing: In suspended polypropylene cages, individually during 24-hour exposure period and group-housed with 5 animals per cage thereafter
- Diet: Ad libitum, Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.
- Water: Ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 47-75
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 25 June 1992 To: 9 July 1992

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 cm * 4 cm
- % coverage: appr. 10% of total body surface area
- Type of wrap if used: surgical gauze held in place by a piece of self-adhesive bandage (HYPERTIE and BLENDERM)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no, exposure area was wiped with cotton wool moistened with distilled water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 2000 mg/ kg bw
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 0.5, 1,2 and 4 hours after dosing and subsequently once daily
- Frequency of weighing: prior to application on day 0 and on days 7 and 14
- Necropsy of survivors performed: yes (gross macroscopy)
- Other examinations performed: any adverse dermal reactions were recorded

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 occurred.
Clinical signs:
No clinical signs were noted during the study.
Body weight:
All animals showed expected body weight gain during the study.
Gross pathology:
The macroscopic observations did not reveal any abnormalities.
Other findings:
Adverse skin reactions were noted for three females: haemorrhage of the dermal capillaries, moderate erythema, keratolysis (glossy skin), small superficial scattered scabs and desquamation. The skin of these treated animals appeared normal 7 days after treatment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
An acute dermal toxicity test was conducted according to OECD/ EC guidelines and GLP principles with PEMP. Based on the results it is concluded that the dermal LD50 of this test substance is > 2000 mg/kg bw.
Executive summary:

An acute dermal toxicity test was conducted according to OECD/ EC guidelines and GLP principles with PEMP. Five male and five female rats were semi-occlusively exposed for 24 hours to 2000 mg/kg bw. No mortality occurred, no clinical signs were noted. Three females were found to have adverse skin reactions, including haemorrhage of the dermal capillaries, moderate erythema, keratolysis (glossy skin), small superficial scattered scabs and desquamation. The skin of these treated animals appeared normal 7 days after treatment.

Based on these data, the dermal LD50 for PEMP was determined to exceed 2000 mg/kg bw, therefore the substance is not classified for dermal toxicity according to Regulation (EC) 1272/2008.