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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Remarks:
source of read across
Adequacy of study:
key study
Study period:
29 March 2017 to 28 April 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
As the acute oral LD50 leads to classification, the acute dermal study cannot be waived.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Similar Substance 01
IUPAC Name:
Similar Substance 01

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain; RccHan:WIST
- Source: Envigo RMS (UK) Limited, Oxon, UK.
- Females nulliparous and non-pregnant:yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: males 255-275 g; females 201-236 g
- Fasting period before study: none
- Housing: 1 male+ 1 females individually; 4 males + 4 females individually during exposure and 4/sex per cage during the rest of the test period in suspended solid floor polypropylene cages furnished with woodflakes
- Diet: 2014C Teklad Global Rodent diet ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- % coverage: ca 10% of body surface
- Type of wrap if used: surgical gauze semi-occluded with a piece of self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes wiped with distilled water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied:2000 mg/kg bw (moistened with distilled water)

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
1 male + 1 female followed by 4 males + 4 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: at 30 minutes, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days (includes signs of irritation)
- Bodyweight: on day 1 7 and 14
- Necropsy of survivors performed: yes
Statistics:
NA

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:
none
Clinical signs:
none
Body weight:
one female did not gain weight
Gross pathology:
no findings
Other findings:
No irritation observed. All animals showed staining of the skin at the test site up to day 4 and one female with scabs

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
The LD50 of the substance is > 2000 mg/kg bw
Executive summary:

In a test according to OECD 402 Wistar rats (5/sex) received 2000 mg/kg bw of the test substance on the skin during 24 hours. During the 14 day observation period no mortality and clinical signs were observed. Body weight was in normal ranges except for one female. Another female developed scabs. No abnormalities were found at necropsy. The LD50 of the substance is > 2000 mg/kg bw.