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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From 27 AUG 1986 to 29 AUG 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
observation time: only up to 48 h
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Methylpentamethylenediamine
- Substance type: clear liquid
- Physical state: fluid
- Analytical purity: 98.5 %
- Impurities (identity and concentrations): Ethyltetramethylenediamine
- Stability under test conditions: the test material was assumed to be stable under the conditions of administration

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hare Marland, Hewitt, New Jersey, USA
- Age at study initiation: young adult
- Housing: single in suspended, stainless steel, wire-mesh cages
- Diet: Purina certified Rabbit Chow (#5322), ad libitum
- Water, ad libitum
- Acclimation period: not mentioned

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-2
- Humidity (%): 50 +/-10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
not specified
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
3 min
Observation period:
3 min, 24 and 48 h after exposure
Number of animals:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 3 min

SCORING SYSTEM: According to Draize Scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 3 min, 24 and 48 h after application
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 48 h after application
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
After 3 min, 24 and 48 h necrosis was visible in all six animals. In the 48 h reading blanching of the skin was also visible.
Edema scores in the 3 min reading were 0 for all animals.

Applicant's summary and conclusion

Interpretation of results:
Category 1A (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the applied test conditions the test substance induced skin corrosion in all six animals.
Executive summary:

A skin irritation/corrosion test was performed with six rabbits. The animals were exposed to 0.5 ml of test substance on the clipped skin for 3 minutes. The skin reactions were observed for 48 h after the initial exposure. All six animals showed severe skin corrosion with necrosis and skin blanching. Severe erythema and necrosis already were visible at the first reading time (i.e. 3 minutes).