Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 Jun - 16 Jul 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

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

Test material

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

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately 10 - 12 weeks
- Weight at study initiation: 179 - 200 g
- Fasting period before study: yes, during designated procedures
- Housing: On arrival, animals were group housed (up to 5 animals of the same sex together) in polycarbonate cages (Makrolon MIV type; height 18 cm.) and following assignment to the study, animals were individually housed in polycarbonate cages (Makrolon MIII type; height 18 cm.) containing sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG, Rosenberg, Germany). For psychological/environmental enrichment, animals were provided with paper (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
- Diet: pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22
- Humidity (%): 32 - 65
- Air changes (per hr): ten or greater
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20 Jun 2018 To: 16 Jul 2018

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 x 7 cm clipped skin of the dorsal area of the trunk
- % coverage: approximately 10%
- Type of wrap: The test material was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned of residual test material using water.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied: 10 mL/kg bw
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Postdose observations were performed at periodic intervals on the day of dosing (at least three times) and once daily thereafter. Animals were weighed individually on Day 1 (predose), 8 and 15.
- Necropsy of survivors performed: yes, all animals
- Other examinations performed: The skin reactions were assessed approximately 24, 48 and 72 hours after the removal of the dressing and test material. Adjacent areas of untreated skin of each animal served as controls.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
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:
No mortality occurred during the study period.
Clinical signs:
2000 mg/kg bw: Piloerection and hunched posture were noted each in 2/3 females on Day 2. Chromodacryorrhoea (snout and/or left eye) was observed in 2/3 females on the day of administration and thereafter in all females on Day 2. 1/3 females showed scales on the treated skin on Days 4 - 5 and hypothermia on Day 2, respectively.
Body weight:
Body weight gains of all dose groups were within the normal ranges in females during the whole study period.
Gross pathology:
Necropsy revealed no substance-related findings.
Other findings:
- Irritation scores: No erythema and edema were observed in all three animals at the 24-, 48- and 72-h reading time points.

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