Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-02-12 to 2012-03-28
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study performed unde GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
2008
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): SD10
- Physical state: Clear, colorless liquid
- Analytical purity: 97.17%
- Purity test date: 2007/05/03
- Lot/batch No.: 9147-192-3a
- Storage condition of test material: room temperature in dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 200 g +- 20%
- Fasting period before study: no
- Housing: suspended solid-floor polypropylene cages with woodflakes as bedding material
- Diet: ad libitum
- Water : ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 deg. C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

IN-LIFE DATES: From: 2012-02-27 To: 2012-03-09

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- % coverage: 10 % of body surface
- Type of wrap if used: surgical gauze plus semiocclusive self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiping with cotton wool moistoned with distileld water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.43 mg/kg bw (specifc gravity: 0.824)

Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: after 1/2, 1, 2, 4 hours after dosing and thereafter once daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, primary irritation on the site of contact, body weight at day 0, 7 and 14

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LDLo
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred during the study period
Clinical signs:
No signs of toxicity were observed.
Body weight:
Nine animals showed body weight loss during the first week, but the expected weight gain during the second week.
Gross pathology:
No gross abnormalities were observed.
Other findings:
Dermal reactions: very slight to slight erythema was noted in all animals throughout the observation period. Very slight to slight oedema was noted in 3 malesand 4 females from day 2 to 3 until day 6 to 13. Several animals showed light brown discoloration of the epidermis, crust formation, haemorrhage of dermal capillaries, blanching of the skin, small superficial scattered scabs, hardened light brown or hardened dark scab, scab cracking, scab lifitng to reveal glossy skin and scab lifitng on edges to reveal dried blood.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was not acutely toxic to rats by the dermal route up to a limit dose of 2000 mg/kg bw. The only effects observed were reversible reductions in body weight and local skin reactions.
Executive summary:

In a standard dermal toxicity test according to OECD TG 402 and GLP in five male and female Wistar rats no mortality was observed at the limit dose of 2000 mg/kg bw. The only effects observed were reversible reductions in body weight and local skin reactions. The substance is therfore not classified for acute dermal toxicity according to EU-Regulation 1907/2006 and amendments and EU Dir 67/548/EEC and amendments.