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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to Guideline study with acceptable restrictions: no details about the test substance; exposure duration max. 2 h; no scoring 72 h after exposure; duration of observation period 8 days

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Isobutylvinylether; no further data

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
2 male White Vienna rabbits,
mean body weight 3.4 kg
standard diets and water ad libitum
Source: GAUKLER, Offenbach, FRG

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin
Amount / concentration applied:
ca. 0.5 mL
Duration of treatment / exposure:
5 min or 2 h
Observation period:
Excess TS was washed off (Lutrol/water). Skin reactions were examined 24 & 48 h and 8 days post treatment.
Number of animals:
2
Details on study design:
A patch (2.5 x 2.5 cm²) soaked with TS was placed to the shaved, intact dorsal skin. It was covered with an inert foil and held in place by an adhesive tape (only 2 h). Contact periods were 5 minutes and 2 hours. Skin reactions were scored according to the table of Draize contained in the OECD TG 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(2 h exposure)
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: score 4 after 8 days plus superficial necrosis in both rabbits (no later scoring)
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(2 h exposure)
Time point:
other: 48 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: score 4 after 8 days (no later scoring)
Irritation parameter:
edema score
Basis:
mean
Remarks:
(2 h exposure)
Time point:
other: 24 & 48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: score 1 after 8 days (no later scoring)

Any other information on results incl. tables

Irritation
Contact period 5 minutes:
Erythema: moderate to severe erythema at 24 and 48 hrs post
treatment developed into slight desquamation until day 8 in
both animals.
Edema: well defined at 24 and 48 hrs post treatment, absent
on day 8 post treatment in both animals.

Contact period 2 hours:
Erythema: moderate to severe erythema at 24 and 48 hrs post
treatment developed into superficial necrosis until
day 8 in both animals.
Edema: well defined at 24 and 48 hrs post treatment, slight
edema on day 8 post treatment in both animals.

Systemic toxicity
No signs noted.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
Score of erythema and edema were 2-3 in two rabbits 24 and 48 h after application of 0.5 mL undiluted test substance and occlusive exposure for 2 h.
Superficial necroses developed within 8 days following application.
Executive summary:

Two White Vienna rabbits receiced 0.5 mL undiluted test substance on the shaved skin. The exposure duration was 2 h under occlusive conditions (then washing off). The skin reactions were examined 24 & 48 h and 8 days post treatment. Score of erythema and edema were 2-3 in two rabbits 24 and 48 h after application, the effects were not reversible; superficial necroses developed within 8 days following application.