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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other: Non-guideline study, non-GLP, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Principles of method if other than guideline:
Two Vienna White rabbits were treated for 3 minutes, 1 hour, and 4 hours, respectively, with the test substance under occlussive conditions. After the application time, the skin was washed with Lutrol or Lutrol/water (1:1) and animals were observed for 8 days.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,5-Dihydrofuran
- Substance No.: 77/746

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: M.Gaukler, 6050 Offenbach
- Weight at study initiation: 3.1, 2.9, 3.6 kg for 4 h, 1 h and 3 min test respectively
- Diet: ad libitum, standard diet Sniff K, standard diet for rabbits and guinea pigs
- Water: ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
3 min, 1 h and 4 h
Observation period:
8 days
Number of animals:
2 per exposure time
Details on study design:
TEST SITE
- Area of exposure: dorsal skin (2 x 2 cm)
- Type of wrap if used: rubber sheet, fixed with adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: Lutrol or lutrol/water 1:1 w/w
- Time after start of exposure: 3 min, 1 h or 4 h

OBSERVATION TIME POINTS
- immediately after exposure, and at 1, 2, and 8 days after exposure

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 and 2 days
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 4 hour exposure
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 and 2 days
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 4 hour exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 and 2 days
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 1 hour exposure
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 and 2 days
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 1 hour exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 and 2 days
Score:
2.75
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 3 minutes
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 and 2 days
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 3 minutes
Irritant / corrosive response data:
- 3 minute test: Immediately after exposure slight erythema and edema was observed. One and two days after exposure severe erythema, strong to severe edema and necrosis was observed. After 8 days severe edema, slight erythema and necrosis was observed.
- 1 hour test: severe erythema and necrosis were observed at all time points in both animals. Immediately after exposure slight edema was observed. One and two days after exposure strong to severe edema was observed. Eight days after exposure slight edema was observed in one animal.
- 4 hour test: slight edema, severe erythema and necrosis were observed at all time points in both animals.
Other effects:
No systemic effects observed.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information