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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
Study period:
2014-07-08 to 2014-07-15
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

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
Details on test material:
- Physical state: Light brown viscous liquid
- Analytical purity: 100%
- Expiration date of the lot/batch: 06 June 2016

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK.
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.45 and 2.49 kg
- Housing: Animals were individually housed in suspended cages.
- Diet: Food (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: 15 air changes/hour
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: From: 2014-07-08 to 2014-07-15

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Test item was used as supplied (undiluted)
- pH of the undiluted test item: 7.0
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4h
Observation period:
Immediately following removal of the patches and approximately 1, 24, 48 and 72 h later, the sites were examined for evidence of primary irritation.
An additional observation was made on Day 7 to assess the reversibility of skin reactions.
Number of animals:
2 females
Details on study design:
TEST SITE
- Area of exposure: On the day of the test a suitable site was selected on the back of each rabbit. A quantity of 0.5 mL of the test item was applied directly to the skin under a 2.5 cm x 2.5 cm cotton gauze patch.
- Type of wrap if used: Treatment site was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing: Four hours after application the corset and patches were removed from animals and any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Very slight erythema was noted at one treated skin site 1 hour after patch removal and at both treated sites at the 24, 48 and 72 hour observations.
Both treated skin sites appeared normal at the 7 day observations.
No corrosive effects were noted.

The test item produced a primary irritation index of 1.0.
Other effects:
Both animals showed expected gain in body weight during the study.

Any other information on results incl. tables

Individual skin reactions

Skin reaction

Observation Time (following patch removal)

Individual score – Rabbit number and sex

Total

74481 Female

74482 Female

Erythema/Eschar Formation

Immediately

0

0

(0)

1 hour

0

1

(1)

24 hours

1

1

2

48 hours

1

1

(2)

72 hours

1

1

2

7 days

0

0

(0)

Edema formation

Immediately

0

0

(0)

1 hour

0

0

(0)

24 hours

0

0

0

48 hours

0

0

(0)

72 hours

0

0

0

7 days

0

0

(0)

Sum of 24 and 72-hour readings (S):        4

Primary Irritation Index (S/4):                     4/4 = 1.0

Classification:                                                MILD IRRITANT

 

( ) = Total values not used for calculation of primary irritation index

Individual body weights and body weight change

Rabbit number and sex

Individual body weight (kg)

Body weight change (kg)

Day 0

Day 7

74481 Female

2.45

2.60

0.15

74482 Female

2.49

2.66

0.17

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions the substance is not classified as irritating to skin according to the criteria of CLP Regulation (EC) No. 1272/2008.
Executive summary:

Test Guidance

OECD guideline 404 and EC Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion).

 

Method and materials

Two New Zealand White female rabbits were dermally exposed to 0.5 mL of the test material for 4 h under a semi-occlusive dressing. After removal of the residual test item, irritation was scored immediately following removal of the patches and approximately 1, 24, 48 and 72 h later, according to Draize method.

 

Results

Very slight erythema was noted at one treated skin site 1 hour after patch removal and at both treated sites at the 24, 48 and 72 hour observations.

Both treated skin sites appeared normal at the 7 day observations.

No corrosive effects were noted.

Both animals showed expected gain in body weight during the study.

The test item produced a primary irritation index of 1.0.

 

Conclusion

Under the test conditions the substance is not classified as irritating to skin according to CLP Regulation (EC) No. 1272/2008.