Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March to April 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
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: Harlan GmbH (Horst, Netherlands)
- Age at study initiation: 8-14 weeks
- Weight at study initiation: 276-308 g for males and 235-259 g for females
- Fasting period before study: none
- Housing: individually in polycarbonate cages on low dust wood granulate bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5
- Air changes (per hr): approx. 10
- 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: 30 cm2
- % coverage: approx. 10
- Type of wrap if used: gauze patch fixed with an elastic adhesive tape pervious to air

REMOVAL OF TEST SUBSTANCE
- Washing (if done): rinsed with tepid water using soap
- Time after start of exposure: approx. 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 18.4-20.5 mg/cm2 (males) and 15.7-17.3 mg/cm2 (females)
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 and weighing: several times on the day of application as well as at least once daily during observation period (clinical signs, mortality); surviving animals were weighed individually at application, after one week and at the end of the 14-day observation period.
- Necropsy of survivors performed: yes
Statistics:
no (limit test)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All male and female animals survived the treatment.
Clinical signs:
At 2000 mg/kg bw reddish encrustations of the nose were observed in all animals. In addition, one female displayed piloerection and sunken flanks on day 15.
Body weight:
There were no toxicologically significant effects on body weight or body weight development. Only one female with clinical signs showed a decrease in body weight in the second week.
Gross pathology:
The necropsies performed at the end of the study revealed no particular findings.
Other findings:
no

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Executive summary:

The acute dermal toxicity of the test substance was low with an LD50 value > 2000 mg/kg bw for male and female rats according to OECD TG 402. Single semiocclusive administration of 2000 mg/kg bw for 24 hours was tolerated without mortalities, effects on body weight gain or gross pathological findings. Clinical signs (reddish encrustations of the nose) were observed in all male and female animals. In addition, one female displayed piloerection and sunken flanks on day 15.