Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007-05-30 to 2007-07-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
February 1984
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
January 1997
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH; D-97633 Sulzfeld;
- Age at study initiation: no data
- Weight at study initiation: 215 - 274 g
- Fasting period before study: no
- Housing: transparent macrolon cages, (type 3-180, floor area 810 sq.cm), two or three animals in each cage, males and females separated
- Diet: pelleted complete rodent diet, Altromin 1314, Altromin GmbH, D-32791 Lage, Lippe; ad libitum
- Water: domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3 °C
- Humidity: at least 30 %, not exceeding 70 %;
- Air changes: 10 times per hour
- Photoperiod: 12 hours light/12 hours dark, light from 6 am to 6 pm

IN-LIFE DATES: From: 2007-05-30 To: 2007-07-04

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 6 x 8 cm
- % coverage: 100
- Type of wrap if used: 4-layer gauze pack fixed with Micropore tap

REMOVAL OF TEST SUBSTANCE
- Washing: with mild soap and lukewarm water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 2000 mg/kg bw

VEHICLE: none
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males/5 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation: 1, 3 and 6 hours after dosing and thereafter daily for a period of 14 consecutive days; weighing: on day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
NA

Results and discussion

Preliminary study:
Prior to the main study a pilot study was performed using one female rat given a dose of 2000 mg/kg bw. Slight signs of toxicosis were observed in this rat.
Based on the results of th pilot study it was decided to carry out the main study with one group consisting of five male and five female animals given a dose of 2000 mg/kg bw.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
neither male nor female rats died on account of the treatment or showed severe signs of toxicosis
Clinical signs:
Male:
Animals No. 2, No. 3, No.4, No.5 and No. 6 appeared apathetically on day 0 after 1 hour, 3 hours and 6 hours. from day 1 to the end of the observation period on day 14 no abnormalities were revealed.
Female:
Animals No. 7, No. 8, No. 9, No. 10 and No. 11 appeared apathetically on day 0 after 1 hour, 3 hours and 6 hours. from day 1 to the end of the observation period on day 14 no abnormalities were revealed.
Body weight:
The rats had a normal body weight gain during the study period
Gross pathology:
The post mortem inspection of the female animals revealed no pathological abnormalities. Two of the male rats (animal No. 2 and No. 5) had marbled kidneys, whereas the remaining animals were inconspiciously.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was not toxic after dermal application.
Executive summary:

The test substance was investigated in accordance with OECD guideline 402 in 5 male and 5 female rats under GLP conditions. No deaths occured during the observation period of 14 days at the limit dose of 2000 mg/ kg bw. Only minimal and transient apathy was observed on day 0. The test substance was not toxic after dermal application.