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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted following the current relevant guideline and fully GLP compliant documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 14-40 weeks
- Weight at study initiation: 3.33-4.35 kg
- Fasting period before study: overnight
- Housing: individually
- Diet: 125 g (Rabbit Diet Pellets) per day
- Water: ad libitum
- Acclimation period: 4 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20°C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: treatment site was ‘wetted’ with 0.5ml of reverse osmosis water
Controls:
other: An additional site was similarly treated with the exception of test substance and acted as a control
Amount / concentration applied:
0.5 g of the test substance
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm2
- Type of wrap if used: porous gauze pad secured with ‘blenderm’ surgical tape

REMOVAL OF TEST SUBSTANCE
- Washing: washed with lukewarm water (30-40°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1-3
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: 1-3
Time point:
other: mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
No sign of irritation was apparent in any animal at any times during the observation period
Other effects:
There was no sign of toxicity or ill health in any rabbit during the observation period

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The Primary Irritation Index was calculated to be 0.0; VRT-126017 dcha was classified as ‘nonirritant’ according to the criteria of the ECETOC and did not require labelling with the risk phrase R38, “Irritating to skin”, in accordance with Commission Directive 2001/59/EC
Executive summary:

Three rabbits received a single four hour, semi-occlusive, dermal administration of approximately

0.5 g of the test substance as supplied and were observed for 72 hours.

No sign of irritation was apparent in any animal at any times during the observation period.