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

Eye irritation

Administrative data

Endpoint:

eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton Texas
- Age at study initiation: no data
- Weight at study initiation: 1.9 - 2.5 kg
- Housing: individually
- Diet: Purina Rabbit Chow, ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eyes of the same animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

30 seconds (3 animals) or continuous ( 6 animals)

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

9

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 300 ml water in 3/9 animals
- Time after start of exposure: 30 seconds, the other animals were not washed

SCORING SYSTEM: comparable to the scoring system described in OECD 405 guideline

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

not washed

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

2.67

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: individual animal scores: 2 in 2/6; 2.67 in 1/6; 3 in 2/6; 3.33 in 1/6 animals

Results 2

Irritation parameter:

iris score

Remarks:

not washed

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

2

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: individual animals scores: 2 in 6/6 animals

Results 3

Irritation parameter:

conjunctivae score

Remarks:

not washed

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

2.28

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: individual animal scores: 2 in 3/6; 2.33 in 1/6; 2.67 in 2/6 animals

Results 4

Irritation parameter:

chemosis score

Remarks:

not washed

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

4

Reversibility:

not fully reversible within: 7 days

Remarks on result:

other: individual animal scores: 4 in 6/6 animals

Any other information on results incl. tables

Corneal ulcerations were present in six unwashed eyes by one hour after treatment and persisted in all six animals through termination of the study. Corneal ulcerations were present in three washed eyes by one hour after treatment and persisted in all three animals through termination of the study.

Conjunctival necrosis was present in six unwashed eyes by twenty-four hours after treatment and persisted in all six animals through termination of the study.

Conjunctival necrosis was present in three washed eyes by twenty-four hours after treatment and persisted in all three animals through termination of the study.

A maximum average irritation score of 58.5 out of a possible 110.0 was obtained at seven days after treatment for unwashed eyes and is considered extremely irritating.

A maximum average irritation score of 40.3 out of a possible 110.0 was obtained at seven days after treatment for washed eyes and is considered severly irritating.

As no reversibility of the ocular effects was seen in all animals upon termination of the study, the test substance causes irreversible effects on the eye.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU