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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other:
Version / remarks:
before the publication of the guideline
Principles of method if other than guideline:
One half ml of the sample was applied to one contact and one abraded skin site under standard gauze patches on each of three albino rabbits. The entire hair clipped truck of each animal was then covered with an impervious sleeve for a period of 24 hours.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
sec-butylamine
EC Number:
237-732-7
EC Name:
sec-butylamine
Cas Number:
13952-84-6
Molecular formula:
C4H11N
IUPAC Name:
butan-2-amine

Test animals

Species:
rabbit
Strain:
other: albino

Test system

Type of coverage:
occlusive
Preparation of test site:
other: applied on one intact and one abraded skin on each of three rabbits
Amount / concentration applied:
one half mL
Duration of treatment / exposure:
24 hours
Observation period:
48 hours
Number of animals:
3 rabbits
Details on study design:
One half ml of the sample was applied to one contact and one abraded skin site under standard gauze patches on each of three albino rabbits. The entire hair clipped truck of each animal was then covered with an impervious sleeve for a period of 24 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 15 minutes
Score:
4
Reversibility:
not reversible
Remarks on result:
other: The skin turned black within 15 minutes.24 hours after initial contact all sites consisted of large, round, black necrotic lesions.
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 15 minutes
Score:
4
Reversibility:
not reversible
Remarks on result:
other: The skin turned black within 15 minutes.24 hours after initial contact all sites consisted of large, round, black necrotic lesions.
Irritation parameter:
edema score
Time point:
other: 15 minutes
Score:
4
Reversibility:
not reversible
Remarks on result:
other: The skin turned black within 15 minutes. 24 hours after initial contact all sites consisted of large, round, black necrotic lesions.

Applicant's summary and conclusion

Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Executive summary:

One half of the sample was applied to one intact and one abraded skin site under standard gauze patches on each of three albino rabbits. The entire hair-clipped trunk of each animal was then covered with impervious sleeve fora period of 24 hours. The sample spread well beyond the intended sites of contact and caused pain in every instance. The skin turned black within 15 minutes.Twenty-four hours after initial contact all trzated sites consisted of large (5cm) round, black, necrotic lesions. These became dry, hard, and concave within 48 hours. Subsequently they began to crack and peel, exposing raw tissues.