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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: No OECD guideline or GLP defined, acceptable restrictions (incomplete documentation).
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
, long exposure duration of 20 hours, no 48 and 72-hour reading
Principles of method if other than guideline:
other: undiluted test substance on the back for 1, 5, 15 min. and 20 h, undiluted testsubstance to the ear for 20 hours, observation time: 8 d (no further information)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material: Benzylamin

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.91 and 3.17 kg

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: back and inner surface of ear
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
back = 1, 5, 15 min and 20 h
ear =20 h
Observation period:
8 d
Number of animals:
2
Details on study design:
TEST SITE (BACK)
- Area of exposure: 2.5 cm x 2.5 cm

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(back)
Time point:
other: 24h and 8 d
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Duration of treatment: 1, 5, 15 min. and 20 h
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(back)
Time point:
other: 24 h and 8 d
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Duration of treatment: 1, 5, 15 min. and 20 h
Irritant / corrosive response data:
Back: Both treated animals showed weak (1min; 5 min) to severe (20 h) necrosis, with an increasing area of necrosis during the observation period.
Ear: Both treated animals showed severe necrosis and at the end of the observation period and on day 8 post application mumifaction of the area of expsoure.

Any other information on results incl. tables

Descriptive scores of the raw data have been converted to Draize numerical scores.

At BASF’s Department of Toxicology, acute toxicity testing was performed according to published methods, which were adapted and standardized for the specific needs of the company, well before Test Guidelines for these methods were established by the OECD beginning 1982. These methods were comparable to the Union Carbide (now a DOW company) range finding toxicity data which have been published in the early toxicological literature (1944-1949). The results of these studies were reported until the early 1980s in summary reports called „Ergebnis der gewerbetoxikologischen Vorprüfung“ or „Toxikologische Grundprüfung“, which do not present details of the methods used, but focus on a summary presentation of the results.

Applicant's summary and conclusion

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