Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21-01-2015 to 04-02-2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study according to the guideline under GLP

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)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
Identification: Fats and Glyceridic oils, vegetable, winterized, reaction products with ammonia-ethanolamine reaction products
Physical state / Appearance: brown extremely viscous liquid
Storage Conditions: room temperature in the dark

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Strain: Wistar (RccHan™:WIST)
- Age at study initiation: 8-12 weeks
- Weight at study initiation: males: 234-250 g; females 206-220 g
- Housing: during 24 h exposure period individually, thereafter 5/sex/cage (suspended solid floor polypropylene cages furnished with woodflakes)
- Diet: 2014C Teklad Global Rodent diet ad libitum
- Water: ad libitum
- Acclimation period: ≥ 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70%
- Air changes (per hr): ≥ 15/hour
- 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 ( % coverage) : 10%
- Type of wrap if used: surgical gauze semi-occluded with a piece of self-adhesive bandage

REMOVAL OF TEST SUBSTANCE: after 24 h exposure treated skin and surrounding hair was wiped with cotton wool moistened with arachis oil BP

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Body weight: at study start and weekly thereafter
- Clinical signs: 1/2, 1, 2, and 4 hours after exposure and then daily for 14 days
- Irritation: after removal of the dressing and daily for 14 days
- Mortality/morbidity: twice daily
- Necropsy : macroscopic examination
Statistics:
NA

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
body weight gain within normal ranges
Gross pathology:
no effects
Other findings:
Signs of skin irritation in 3 males and all females (very slight to well-defined erythema, very slight oedema, crust formation, hemorrhage of dermal capillaries, small superficial scattered scabs and scab lifting to reveal glossy skin)

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 for dermal toxicity is > 2000 mg/kg bw
Executive summary:

Wistar rats (5/sex) were dermally exposed to the substance for 24 hours (semi occlusion) at 2000 mg/kg bw. No mortality, clinical signs or macroscopic changes were seen. Body weight gain was within normal ranges. Most animals showed signs of irritation. The LD50 is > 2000 mg/kg bw