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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Study period:
23 Jan - 27 Jan 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
lack of details on test substance
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Isopropyl isodecanoate
EC Number:
269-023-3
EC Name:
Isopropyl isodecanoate
Cas Number:
68171-33-5
IUPAC Name:
68171-33-5
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: very light yellow liquid
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage Des Feuilletas (40 - Campet Lamolere)
- Weight at study initiation: 2 ± 0.2 kg
- Housing: individual in stainless steel cages (61 x 46 x 34 cm) with a grid floor
- Diet: food (UAR 112) ad libitum
- Water: tap water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 14
- Photoperiod: 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites treated with 0.5 mL water under similar conditions as for the substance-treated site.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100%
Duration of treatment / exposure:
4 hours
Observation period:
72 hours

Reading time points: 1 hour after the removal of the dressing and 24, 48 and 72 hours after application
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm²
- Type of wrap if used: The test substance was applied on a Codex hydrophilic eight layer gauze. The gauzes were kept into contact with the skin, using a hypoallergenic microporous adhesive strip of 50 mm wide. The wole was covered with a stretchable band (fixed with adhesive tape) wraped round the animal without any restraint for the respiratory and abdominal movements.

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: Reversibility: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: Reversibility: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: Reversibility: not applicable
Irritant / corrosive response data:
Very slight erythema was observed in all 3 animals at reading time point 1 and persisted in one case until 24 h. The effect was fully reversible within 48 hours. Very slight edema was seen in one animal at reading time point 1 h, which however was no more evident at 24 h.
Other effects:
None

Any other information on results incl. tables

Table 1: Individual skin examination scores (Scoring according to Draize scheme)

Skin effect

Erythema

Edema

Scoring

1h

24h

48h

72h

Meana

1h

24h

48h

72h

Meana

Animal No.

#1

1

1

0

0

0.33

1

0

0

0

0

#2

1

0

0

0

0

0

0

0

0

0

#3

1

0

0

0

0

0

0

0

0

0

aMean of 24, 48 and 72 h scores

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified