Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1963
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The test was conducted according to a BASF internal test method, which in principle was similar to OECD 404, however with following deviations: Exposure periods of 1, 5,15 minutes and 20 h (OECD recommendation: 4 h); Testing of the ear (not recommended by the OECD guideline); Time point 72 h not considered; Observation period of 8 days instead of 14 as recommended by OECD guideline. These deviations did not affect the validity and reliability of the findings; the study is scientifically acceptable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report date:
1963

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(1981)
Principles of method if other than guideline:
The test was conducted according to an internal BASF test method, which in principle was similar to OECD 404.
BASF-TEST:
White Vienna rabbits were used. Usually, 2 animals were treated for 1, 5, 15 min and 20 h using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the liquid test substance. In addition, skin tissue from the ear was tested by wrapping the ear. These results from the ear, however, would not be taken into account for evaluation as they do not represent testing of the dorsal/lateral flank of the back. After the application time, the skin was washed with water which sometimes contained a mild detergent. The animals were observed for 8 days. Skin reaction was recorded after 1h, 24h, 48h, 72h, 96h and after 7 and 8 days.
GLP compliance:
no
Remarks:
GLP was not compulsory at the time the study was conducted

Test material

Constituent 1
Chemical structure
Reference substance name:
Glyoxal
EC Number:
203-474-9
EC Name:
Glyoxal
Cas Number:
107-22-2
Molecular formula:
C2H2O2
IUPAC Name:
oxalaldehyde
Test material form:
liquid

Test animals

Species:
rabbit

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: none as the test substance was applied unchanged
Controls:
other: untreated skin of the same animal served as control
Amount / concentration applied:
the test substance was applied undiluted to the skin using a patch soaked with test material; the applied amount was about 1 mL.
Duration of treatment / exposure:
Dorsal skin: 1, 5, 15 min
Dorsal skin: 20 h
Ear: 20 h
Observation period:
The animals were observed following exposure for 8 days on working days. Skin changes were recorded after removal of the bandage as well as after 1h, 24h, 48h, 72h, 96 h and after 7 and 8 days.
Number of animals:
Four animals were used.
Details on study design:
- Each animal received an application of test material to the clipped dorsal skin of the trunk and to the ear. The test material was used unchanged at a volume of 1 mL and the application site was maintained under occlusive conditions. 
-Following application periods of 1, 5 and 15 minutes (dorsal skin),  dressing was removed and the application site was rinsed with Lutrol and  Lutrol in water (1:1).
- Following application periods of 20 hours (dorsal skin and ear), the  dressing was removed but the application site was not rinsed.  The animals were observed and skin findings were recorded over a period  of 8 days following treatment.
-The skin findings, which had been originally scored according to a BASF  scoring system, were re-scored according to the OECD Draize scoring  system; for this purpose, only the findings of the 20-hour dorsal application were considered at the time point 24 and 48 hours (no 72 h data provided).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
1 min and 5 min exposure
Basis:
mean
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Remarks:
15 min exposure
Basis:
mean
Time point:
24 h
Score:
2
Reversibility:
not fully reversible within: 8 days
Remarks:
distinct scaling
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
mean
Time point:
24 h
Score:
2
Reversibility:
not fully reversible within: 8 days
Remarks:
necrosis
Irritation parameter:
edema score
Remarks:
15 min exposure
Basis:
mean
Time point:
24 h
Score:
2
Reversibility:
not fully reversible within: 8 days
Remarks:
distinct scaling
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
mean
Time point:
24 h
Score:
3
Reversibility:
not fully reversible within: 8 days
Remarks:
necrosis
Other effects:
- After 1 and 5 minutes: at reading time point 24 hour, slight erythema was seen; full reversibility was reported for day 8.
- After 15 minutes: at reading time point 24 hours, slight edema and slight erythema were observed; at day 8 fine scaling was seen, indicating partial reversibility.
- After 20 hours: erythema, edema and slight skin defects were seen within 24 h; eschar formation and slight necrosis were seen within 8 days.

Any other information on results incl. tables

The 20-hour dorsal treatment which was relevant for assessment resulted in erythema and edema; after 8 days, severe necrosis was seen, indicating no reversibility.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria