N,N'-bis(1,3-dimethylbutylidene)-2,2'-iminobis(ethylamine)

Skin irritation / corrosion

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: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Initial Submission: Letter submitting two enclosed irritation studies and one enclosed toxicity study on Epon Curing Agent H-1 with attatchments

Author:

US EPA

Year:

1991

Bibliographic source:

OTS0534688; New Doc ID: 88-920000220; Old Doc ID: 8EHQ-1191-1584

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Draize-Test

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-bis(1,3-dimethylbutylidene)-2,2'-iminobis(ethylamine)

EC Number:

234-205-3

EC Name:

N,N'-bis(1,3-dimethylbutylidene)-2,2'-iminobis(ethylamine)

Cas Number:

10595-60-5

Molecular formula:

C16H33N3

IUPAC Name:

N-(1,3-dimethylbutylidene)-N'-{2-[(1,3-dimethylbutylidene)amino]ethyl}ethane-1,2-diamine

Details on test material:

- Name of test material (as cited in study report): Epon Curring Agent H-1
- Physical state: liquid
- Analytical purity: 94 %
- Impurities (identity and concentrations):
CAS # 108-10-1 (Methyl isobutyl keton): 1.4 %
CAS # 111-40-0 [2,2'-iminodi(ethylamine)]: 4.4 %
water: 0.2 %
- Stability under test conditions: no data
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton Texas
- Age at study initiation: no data
- Weight at study initiation: 2.0 - 2.4 kg
- Housing: individually
- Diet: Purina Rabbit Chow, ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
no data

Test system

Type of coverage:

occlusive

Preparation of test site:

other: one intact (shaved) and one abraded test site per animal

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml per test site

Duration of treatment / exposure:

24 hours

Observation period:

72 houres

Number of animals:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm tap water
- Time after start of exposure: after the 24 hours of exposure and the first reading of skin effects

SCORING SYSTEM: comparable to the scoring system described in OECD 404 guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

3.92

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: scores based on intact skin sites, full thickness necrosis was observed in each animals

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

4

Reversibility:

not fully reversible within: 72 hours

Remarks on result:

other: scores based on intact skin sites

Any other information on results incl. tables

Erythema was present throughout the study and averaged 3.96 (severe erythema). Edema was present throughout the study and averaged 4.00 (severe edena). The primary irritaton score was determined to be 7.96 out of possible 8.00. Necrosis was present on each test site on each animal at each observation time.

The substance was corrosive to the skin due to the full thickness necrosis observed in each animal after 24 hours of exposure.

Applicant's summary and conclusion

Interpretation of results:

Category 1C (corrosive)

Remarks:

Migrated information Criteria used for interpretation of results: EU