Cyclohex-1,2-ylenediamine

Skin irritation / corrosion

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

Results

Results 1

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

Results 2

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).