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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Principles of method if other than guideline:
Method: BASF-Test. One animal was treated for 3 min using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application time (3 min) the skin was washed with Lutrol and Lutrol/water (1:1). The animal was observed for 72 h and skin changes were recorded daily. The report describes findings after 4, 24, 48 and 72 hours. For the evaluation, the findings after 24, 48 and 72 hours were taken into account. The assessment is based on J.H. DRAIZE: Appraisal of the safety of chemicals in foods, drugs and cosmetics. Dermal Toxicity p. 46 – 59, 1959.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopentylamine
EC Number:
203-526-0
EC Name:
Isopentylamine
Cas Number:
107-85-7
Molecular formula:
C5H13N
IUPAC Name:
isopentylamine
Details on test material:
- Name of test material (as cited in study report): Isopentylamin

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: GAUKLER; Offenbach, Germany
- Weight at study initiation: 2.07 kg
- Housing: single housing
- Diet: KLIBA 341, 4mm; Klingentalmuehle AG, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: at least 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): about 0.5 ml
Duration of treatment / exposure:
3 min
Observation period:
72 h
Number of animals:
1
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was washed with Lutrol (conc.) and Lutrol/water (1:1).
- Time after start of exposure: After the 3 min exposure time.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 h - 48 h - 72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: only one animal was used.
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 h - 48 h - 72 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: only one animal was used.

Any other information on results incl. tables

Results skin irritation:

 Reading:  Erythema  Edema  Symptoms    
 4 h  4  0  N    
 24 h  4  2  N    
 48 h  4  2  N    
 72 h  4  1  TN/+    

N: necrosis.

TN: Full thickness necrosis.

+: findings confirmed by gross pathology examination.

After a 3 min exposure necrosis occured after 4 h and after 72 h full thickness necrosis was observed.

Corrosive.

Applicant's summary and conclusion

Conclusions:
Isopentylamine requires classification (CLP regulation: corrosive, Cat 1A)