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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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: Study meets generally accepted scientific standards, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
only two animals tested
Principles of method if other than guideline:
The skin irritation test was conducted according to a BASF-internal standard protocol. Two White Vienna rabbits were treated with the substance for 1 min, 5 min, 15 min, and 20 h, respectively, under occlusive conditions.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Hexylamine
EC Number:
203-851-8
EC Name:
Hexylamine
Cas Number:
111-26-2
Molecular formula:
C6H15N
IUPAC Name:
hexan-1-amine

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.74 and 2.92 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: approx. 1 mL
Duration of treatment / exposure:
1 min, 5 min, 15 min, 20 hrs
Observation period:
8 d
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: patch, no further data


REMOVAL OF TEST SUBSTANCE
- Washing: yes (exposure 1, 5, 15 min) first with undiluted Lutrol 9, then with an aqueous Lutrol solution (50 %); no (exposure 20 hrs)
- Time after start of exposure: 1, 5, and 15 min, respectively


SCORING SYSTEM:
The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: necrosis
Basis:
animal #1
Remarks:
(exposure time: 1 min, 5 min, 15 min)
Time point:
other: 24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Full thickness necrosis (dark, hard) observed at the 24 h, 48, and 72 h readings
Irritation parameter:
other: necrosis
Basis:
animal #2
Remarks:
(exposure time: 1 min, 5 min, 15 min)
Time point:
other: 24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Full thickness necrosis (dark, hard) observed at the 24 h, 48, and 72 h readings
Irritation parameter:
other: necrosis
Basis:
animal #1
Remarks:
(exposure time: 20 h)
Time point:
other: 24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Full thickness necrosis (dark, hard) observed at the 24 h, 48, and 72 h readings
Irritation parameter:
other: necrosis
Basis:
animal #2
Remarks:
(exposure time: 20 h)
Time point:
other: 24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Full thickness necrosis (dark, hard) observed at the 24 h, 48, and 72 h readings
Irritant / corrosive response data:
In both animals after exposure time intervals of 1 min, 5 min, 15 min, respectively, red-brown soft necrosis, i.e. superficial necrosis was noted immediately after removal of the test patches. At the following readings starting 24 hours after exposure, dark, hard necrosis, i.e. full thickness necrosis was observed at the application area. In addition, at the margins of the exposed area slight erythema (Draize score: 2) was observed in one animal after 1 min, 5 min, and 15 min exposure, respectively. At the last reading 8 days after exposure, full thickness necrosis was still present in both animals, irrespective of the exposure time.

Applicant's summary and conclusion

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