Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted in 2017
Deviations:
yes
Remarks:
occlusive dressing, males and females tested, no stepwise approach, limited information, dilution of substance
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Cpb:Wu
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Central Institute for the Breeding of Laboratory Animals TNO, Zeist, The Netherlands
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: males: 310 to 376 g; females: 170 to 210 g
- Fasting period before study: no
- Housing: groups of five, males and females separated, in stainless steel cages with grid-bottom and front
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 2 months

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 1
- Humidity (%): 40 - 60
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal and ventral side of the trunk and flanks
- % coverage: not specified
- Type of wrap if used: plastic film secured by an elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water and handsoap
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 8 mL/kg bw
- Concentration: 25%
- Constant concentration used: yes
Duration of exposure:
24 hours
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 and weighing: Skin readings were made immediately after dressing removal, and after a period of three days. The rats were observed for signs of intoxication frequently during the application period and once daily throughout the observation period of 14 days. Body weights were recorded on Day 0, 7 and 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed.
Clinical signs:
No signs of intoxication.
Body weight:
Individual body weights of the rats on Days 7 and 14 indicated growth retardation in the first post-treatment week and recovery to normal growth thereafter. The following body weights were measured for male rats: Day 0: 330 g, Day 7: 334 g, Day 14: 365 g and for female rats: Day 0: 204 g, Day 7: 206 g, Day 14: 217 g
Gross pathology:
No treatment-related gross alterations
Other findings:
- Skin observations: Skin readings after 24 hours and after 3 days were negative.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008