Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 Oct - 08 Nov 2016
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 24 Feb 1987
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
The Department of Health of the Government of the United Kingdom, UK
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Remarks:
RccHan™:WIST
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Envigo RMS (UK), Limited, Oxon, UK
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 227 - 249 g (males); 209 - 221 g (females)
- Housing: The animals were housed individually during the exposure period and in groups of 5 animals per sex in suspended solid floor polypropylene cages furnished with woodflakes.
- Diet: 2014C Teklad Global Rodent diet (Envigo RMS (UK) Limited, Oxon, UK), ad libitum
- Water: Trinking water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): At least 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
DMSO
Remarks:
as moistener
Details on dermal exposure:
TEST SITE
- Area of exposure: clipped skin of the dorsal area of the trunk
- % coverage: 10
- Type of wrap if used: A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage. Shortly after dosing the dressings were examined to ensure that they were securely in place.

REMOVAL OF TEST SUBSTANCE
- Washing: Yes, the treated skin and surrounding hair was wiped with cotton wool moistened with DMSO to remove any residual test item.
- Time after start of exposure: 24 h
Duration of exposure:
24 h
Doses:
2000 mg/kg bw (due to the purity of the test material, the animals were dosed with 2218 mg/kg bw of the test material)
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 deaths or overt signs of toxicity 30 min, 1, 2 and 4 h after dosing and thereafter once daily for 14 days. The body weights were determined prior to the treatment and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other: The test sites were examined for evidence of primary irritation after removal of the test substance and subsequently once daily for 14 days, and scored according to the Draize scoring system.

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 at the dose level of 2000 mg/kg bw.
Clinical signs:
There were no systemic clinical signs noted in any animal throughout the study. Very slight erythema (grade 1) was observed at the test sites of all animals up to 5 or 6 days after treatment with the test substance. Crust formation was noted at the test sites from Day 6 to Day 7 or 8 in 4/5 males and 4/5 females. Small superficial scattered scabs were observed at the test site of one male from Day 4 to Day 14.
Body weight:
Body weight gains of the treatment group were within the normal ranges in males and females during the whole study period.
Gross pathology:
Necropsy revealed no substance-related findings.

Any other information on results incl. tables

Table 1 Individual Dermal Reactions

Males   Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Day 8 Day 9 - 14
1 Erythema 1 1 1 1 1 0 0 0 0
  Other 0 0 0 0 0 Cf Cf 0 0
2 Erythema 1 1 1 1 1 0 0 0 0
  Other 0 0 0 0 0 Cf Cf 0 0
3 Erythema 1 1 1 1 1 0 0 0 0
  Other 0 0 0 0 0 Cf Cf Cf 0
4 Erythema 1 1 1 1 1 0 0 0 0
  Other 0 0 0 0 0 Ss Ss Ss Ss
5 Erythema 1 1 1 1 1 0 0 0 0
  Other 0 0 0 0 0 Cf Cf Cf 0
Females                    
1 Erythema 1 1 1 1 1 0 0 0 0
  Other 0 0 0 0 0 Cf Cf 0 0
2 Erythema 1 1 1 1 1 0 0 0 0
  Other 0 0 0 0 0 Cf Cf 0 0
3 Erythema 1 1 1 1 1 0 0 0 0
  Other 0 0 0 0 0 Cf Cf Cf 0
4 Erythema 1 1 1 1 1 1 0 0 0
  Other 0 0 0 0 0 0 0 0 0
5 Erythema 0 0 0 0 0 0 0 0 0
  Other 0 0 0 0 0 Cf Cf 0 0

0 = No reaction

Cf = Crust formation

Ss = Small superficial scattered scabs

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