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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
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically acceptable study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
According to BASF-internal standard, see details in the section "Any other information on materials and methods incl. tables".
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
Mean body weights of the rabbits: 2.85 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal served as control.
Amount / concentration applied:
ca. 1 mL
Duration of treatment / exposure:
3 minutes
Observation period:
8 days
Number of animals:
2
Details on study design:
Application area: 2.5 x 2.5 cm

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: parchment-like necrosis (comprehensive)
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks on result:
other: comprehensive
Irritation parameter:
erythema score
Basis:
animal: #1, #2
Time point:
other: 3 min
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: necrosis observed, overarching skin reaction
Irritation parameter:
edema score
Basis:
animal: #1, #2
Time point:
other: 3 min
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: overarching skin reaction
Other effects:
Pathology: The skin effects of the sacrificed animals were macroscopically confirmed.

Applicant's summary and conclusion

Interpretation of results:
highly corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

In a skin irritation/corrosion study (BASF, 1980), 2 Vienna White rabbits were treated with undiluted test substance for 3 min using occlusive conditions. An application site of 2.5 cm² was covered with ca. 1 mL of the liquid test substance. The animals were observed for 8 days and skin changes were recorded daily. For a final evaluation, the findings from 24 and 48 hours from the raw data were taken into account on a mean basis (erythema score, edema score). The application for 3 min evoked after 3 min strong skin reactions and caused after 24 hours leathery-like necrosis in both animals. Parchment-like necrosis was observed after 8 days. This study is classified as acceptable. It generally satisfies the guideline requirements for OECD 404.