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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 Mar - 24 Mar 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Current version adopted in 2015
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Guideline in place during study conduct: adopted in 2002
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
National Good Laboratory Practice (GLP) Compliance Monitoring Authority (NGCMA), Department of Science and Technology, Government of India

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
446-630-3
EC Name:
-
Cas Number:
181587-01-9
Molecular formula:
C13H9Cl2F3N4OS
IUPAC Name:
5-amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-(ethanesulfinyl)-1H-pyrazole-3-carbonitrile

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Sri Raghavendra Enterprises, Bangalore, India
- Age at study initiation: 8 months
- Body weight at study initiation: 2.41 - 2.74 kg (females)
- Housing: individually, in stainless steel cages (sized: 60 cm (L) x 45 cm (W) x 45 cm (H)) provided with stainless steel mesh bottom
- Diet: extruded pelleted rabbit feed 'Amrut' (Pranav Agro Industries Ltd., Sangli, India), ad libitum
- Water: filtered and UV irradiated water in drinking water quality, ad libitum
- Acclimation period: 7 - 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22
- Humidity (%): 48 - 64
- Air changes (per hr): 12.36
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17 Mar 2016 To: 24 Mar 2016

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
The test substance was moistened with water.
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g, moistened with water at the time of application
Duration of treatment / exposure:
Initial test: 3 min, 1 h and 4 h
Confirmatory test: 4 h
Observation period:
Initial test: 3 days; reading time points: immediately after the patch was removed after 3 min, 1 and 4 h exposure and 1, 24, 48 and 72 h post exposure (after removing the patches)
Confirmatory test: 3 days; reading time points: 1, 24, 48, and 72 h post 4-h exposure (after removing the patches)
Number of animals:
3 animals in total (initial test: 1 animal, confirmatory test: 2 animals)
Details on study design:
TEST SITE
- Area of exposure: 6 cm² on the dorsal skin of the animal
- Type of wrap: The applied test substance was covered with a gauze patch, the latter being fixed with a gauze bandage wrapped around the animal and secured with tape.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test substance was wiped off and the treatment area was gently washed with analytical grade water.
- Time after start of exposure: 4 h

SCORING SYSTEM:
Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test substance did not cause any skin reaction in the form of erythema or oedema in neither of the animals tested.
Other effects:
No clinical signs of systemic toxicity were observed. Body weights were not affected during the study period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified