Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 Jan - 22 Mar 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted in Oct 2017
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories Japan (Hino Breeding Center), Japan
- Age at study initiation: 7 weeks (males); 9 weeks (females)
- Weight at study initiation: 251.9 - 266.7 g (males); 209.8 - 224.6 g (females)
- Housing: animals were individually housed in stainless steel cages with mesh-floor (260W x 380D x 180H mm).
- Diet: pelleted diet (MF, lot No. 160915, Oriental Yeast), ad libitum
- Water: chorinated water (3 - 5 ppm by adding sodium hypochlorite to Hita City supply water), ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 13 Jan 2017 To: 22 Mar 2017

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
CMC (carboxymethyl cellulose)
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 x 5 cm clipped skin of the dorsal are of the trunk
- Type of wrap if used: The test material was held in contact with the skin with a non-woven gauze covered and fixed by elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The non-woven gauze and elastic adhesive bandage were removed and residual test substance was removed using purified water and absorbent cotton
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 10 mL/ kg bw
- Concentration: 20% (w/v)
- Constant volume or concentration used: yes
Duration of exposure:
24 h
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: The animals were observed for signs of toxicity or mortality continuously for 10 min after the application, and were observed once 30 min and 3 h after the application. Thereafter, the animals were observed once daily from 1 to 14 days after the application.
- Necropsy of survivors performed: yes, all animals were subjected to a gross necropsy 14 days after application
- Other examinations performed: body weights were recorded prior to the application, and on day 7 and 14 after the application.

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 occurred during the study period.
Clinical signs:
2000 mg/kg bw: slight decreased spontaneous locomotion was sporadically observed in all animals of both sexes from 5 min to 3 h after the application, and disappeared after removal of the non-woven gauze and elastic adhesive bandage on the next day of the application in all animals.
Body weight:
No abnormalities were observed in any animals.
Gross pathology:
Necropsy and revealed no substance-related findings.

Applicant's summary and conclusion

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