Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-01-25 to 2000-02-08
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
February 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
29 Decembre 1992
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Remarks:
HsdCpb: WU
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: F. Winkelmann, 33178 Borchen, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 7 to 10 weeks
- Weight at study initiation: 217 g (range from 202 to 240 g)
- Housing: separately in Makrolon cages type III
- Diet: ad libitum, diet (Altromin Standard Diät TPF®N 1324)
- Water: ad libitum, tap water
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 38 - 66
- 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: backs and abdomens, area of 6 x 6 cm
- Type of wrap if used: self-adhesive fabric (Fixomull stretch, Beiersdorf)

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 1.7 mL/kg
Duration of exposure:
24 h
Doses:
2000 mg/kg
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 and weighing: daily, weighing was performed on days 2, 4, 6, 8, 11, 13, and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
The body weight data were recorded with the PC-program „AKUDAT". The statistical evaluations of the body weight were carried out with the PC-program „TOX 511 A", developed by the Institute of Toxicology of Merck KGaA, Darmstadt. The body weight development of each rat and group was determined. The group mean value was calculated for each measurement.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
All the rats survived the observation period.
Clinical signs:
No signs of intoxication and no signs of local irritation occurred after treatment.
Body weight:
An inhibition of body weight, released from the tape, was observed on day two of the experimental part. Later on the body weight development of the treated rats was inconspicuous.
Gross pathology:
All rats which were sacrificed at the end of the study showed no macroscopic abnormalities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the present study, the test item has no acute toxic potential and the LD50 value is higher than 2000 mg/kg bw after single dermal administration to male and female rats.
Executive summary:

The test substance was tested for acute toxicity in rats after dermal administration of 2000 mg/kg body weight in accordance with OECD guideline 402. Groups of Wistar rats (5/sex) were dermally exposed to the test substance for 24 hours. The test material was a liquid and was spread on the shaven skin in an area of 6 x 6 cm covered with a gauze patch. This was kept in place by a self-adhesive fabric (Fixomull® stretch, Beiersdorf). The gauze and adhesive fabric were removed after exposure time and any remaining test material was wiped off carefully. Animals were then observed for 14 days.

No signs of toxicity were detected in the rats after treatment with 2000 mg/kg. Weight development was not affected by the treatment. There were no deaths during the course of the study. The gross pathological examination revealed no organ alterations.

Based on the result of this study, the test substance can be considered to have no acute toxic potential and to have a LD50 value higher than 2000 mg/kg after dermal application to rats.