Registration Dossier

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:
1986-06-17 to 1986-06-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): isopropyl myristate
- Physical state: colourless liquid
- Analytical purity: approx. 100%
- Storage condition of test material: RT in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Sex: Male
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 12 weeks
- Weight at study initiation: approx. 3000 g
- Diet: 100 g/day (Standart laboratory animal diet LK-01)
- Water: ad libitum
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 23
- Humidity (%): 60-85
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 mL
Duration of treatment / exposure:
4h
Observation period:
1h, 24h, 48h, 72h and 7d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: air- and vapor permeable gauze-patch fixed with a flexible bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, using a tissue moistened with tap-water


SCORING SYSTEM: According to the criteria for irritancy and corrosiveness on the skin, Off. J. Europ. Commun., L 180/56 (91/325/EEC) (Draize)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 480
Time point:
other: average 24, 48 and 72h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
erythema score
Basis:
animal: 481
Time point:
other: average 24, 48 and 72h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
erythema score
Basis:
animal: 487
Time point:
other: average 24, 48 and 72h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7d
Irritation parameter:
edema score
Basis:
animal: 480
Time point:
other: average 24, 48 and 72h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal: 481
Time point:
other: average 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
edema score
Basis:
animal: 487
Time point:
other: average 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
The test substance caused very slight erythema dissappearing completely within 7 days. Only one animal had slight edema up to 48 h after application.

Any other information on results incl. tables

Erythema score

Animal Number

24 h

48 h

72 h

7 days

Mean

(24-72 h)

480

1

1

1

0

1.0

481

1

1

1

0

1.0

487

1

1

1

0

1.0

 

Edema Score

Animal Number

24 h

48 h

72 h

7 days

Mean

(24-72 h)

480

1

1

0

0

0.66

481

0

0

0

0

0.0

487

0

0

0

0

0.0

 

According to DSD and CLP the test substance has not to classified.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information