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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:
from 1998/09/14 to 1998/09/25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD guideline N°404 in compliance with GLP. Substance analytical certificate not available
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

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)
Principles of method if other than guideline:
Guideline study
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): DEV 98-25
- Substance type: petroleum product, UVCB
- Composition of test material, percentage of components: Hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, <2% aromatics
- Physical state: bright and clear, colourless liquid
- Analytical purity: 100% Commercial product
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
other: SPF
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Russian from Mollegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved.
- Age at study initiation: no data
- Weight at study initiation: 2.1-2.5 kg
- Housing: individually
- Diet (e.g. ad libitum): A pelleted complete rabbit "Altromin 2123" diet ad libitum
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): 12 h/ 12h


IN-LIFE DATES: no data

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: Electric clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL, undiluted
Duration of treatment / exposure:
4 hours
Observation period:
Skin reaction assessed at 1, 24, 48 and 72 hours and 7 days after exposure (after the removal of the patch)
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: ca. 2.5 cm X 2.5 cm (left+ right)
- % coverage: no data
- Type of wrap if used: Nobifix (6 cm width) was loosely wound round the trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test substance was cleaned with lukewarm water and mild soap
- Time after start of exposure: 4 hours


SCORING SYSTEM: in accordance with the OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.2
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
See Table I, the test substance is slightly irritating:
- The mean individual erythema scores were 0.2, 0.3 and 0.5 respectively
- The mean individual oedema scores were 0.7, 0.0 and 0.0 respectively
Other effects:
none

Any other information on results incl. tables

Table I: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 4

24 h

L: 1/1/1

     R: 0/1/1

L and R: 0/0/0

48 h

L: 0/0/0

     R: 0/0/1

L: 1/0/0

R: 1/0/0

72 h

      L: 0/0/0

      R: 0/0/0

L: 1/0/0

R: 1/0/0

Average 24h, 48h, 72h

L+R: 0.2 -0.3- 0.5

L and R: 0.7-0-0

Reversibility*

C

C

Average time (unit) for reversion

within 72 hours

within 7 days

L: left test flank R: right test flank C: completely reversible

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, DEV 98-25 is not classified as skin irritant according to the criteria of Annex VI of the Directive 67/548/EEC and CLP Regulation 1272/2008.
Executive summary:

In a primary dermal irritation study conducted according to OECD guideline N°404, three rabbits were exposed to 0.5 mL of DEV 98-25 at two skin sites on the back.

Test sites were covered with a semi-occlusive dressing for 4 hours. Animals then were observed for 7 days. The skin reactions were assessed at 1, 24, 48 and 72 hours, as well as 7 days after removal of the dressing. The mean score was calculated across 3 scoring times; 24, 48 and 72 hours after patch removal, for each animal separately.

The mean individual scores were 0.2, 0.3 and 0.5 for erythema and 0.7, 0.0 and 0.0 for edema.

Based upon the directive 67/548/EEC and the CLP Regulation 1272/2008, DEV 98 -25 is not considered as irritating to the rabbit skin.