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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, guideline study, adequate for assessment

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Di-n-butene. According to the report's owners the substance di-n-butene can be classified as CAS 11071-47-9 (Isooctene).
Components: 18 % n-Octene, 58 % Methylheptene and 24 % Dimethylhexene

Test animals

Species:
rabbit
Strain:
other: small white russian CHbb-SPF
Details on test animals and environmental conditions:
TEST ANIMALS
- Acclimitisation: 14 days
- Weight at study initiation: 2.2-2.3 kg
- Housing: stainless steel cages
- Diet (e.g. ad libitum): K4 Alleindiat for rabbits
- Water (e.g. ad libitum): tapwater
- Acclimation period: no information


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.5 cm3
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours post treatment and then at 6, 8, 10 and 14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: ~6 cm2
- Type of wrap if used: Gauze (2.5 x 2.5 cm) and then with polyethylene film (6 x 6 cm), bound on to the animal.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes (warm water)
- Time after start of exposure: 4 hours


SCORING SYSTEM: OECD method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
2.22
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72 hours
Score:
1.22
Max. score:
4
Reversibility:
not fully reversible within: 14 days

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information
Conclusions:
Di-n-butene was irritating to rabbit skin after application of 0.5 cm3 test substance.