Reaction mass of 7-azatridecane-1,13-diamine and hexamethylenediamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given: comparable to guidelines /standards

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

: one additional animal

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: DRAIZE test published in "Appraisal of the safety of chemicals in foods and cosmetics" Association of Food and Drug Officials of the United States, published by the Editorial Committee, Baltimore (1959), p. 46

Deviations:

no

GLP compliance:

no

Remarks:

study performed before GLP statement

Test material

Test material information

Constituent 1

Reference substance name:

bis(6-aminohexyl)amine; hexane-1,6-diamine

EC Number:

907-605-7

Cas Number:

68815-47-4

Molecular formula:

C6H16N2 (HMD) C12H29N3 (BHT)

IUPAC Name:

bis(6-aminohexyl)amine; hexane-1,6-diamine

Details on test material:

- Name of test material (as cited in study report): 22983 R.P. (produit technique); Bis Hexamethylene triamine, culot de distillation
- Physical state:solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2 to 2.6 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

Substance application was performed once, without any washing subsequently.

Observation period (in vivo):

7 days (Ocular reactions were observed at 1hour, 24, 48 and 72 hours after the instillation and then at days 7.)

Number of animals or in vitro replicates:

4

Details on study design:

SCORING SYSTEM: according to OECD TG 405 (Draize scale), reading at 1 h, 1, 2, 3, 4 and 7 days after removal of test item

The test item was instilled into the lower conjunctival sac of the left eye of each test animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24,48 and 72 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days post application

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24,48 and 72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks:

within 7 days post application

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

other: 24,48 and 72 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Remarks:

within 7 days post application

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24,48 and 72 h

Score:

3.67

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days post application

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24,48 and 72 h

Score:

3.3

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days post application

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24,48 and 72 h

Score:

3.67

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days post application

Results 7

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

other: 24,48 and 72 h

Score:

3.67

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days post application

Irritant / corrosive response data:

Within 2 days post instillation the reading of all characteristics (i.e. corneal opacity, iris, conjunctivae redding, chemosis) resulted in maximum scores (see above), which were not reversible within 7 days post application.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions tested the test item was corrosive to eyes.

Executive summary:

The primary eye irritation potential of the test item was investigated similar as described in OECD testing guideline no 405. The test item (0.1 g) was applied into the lower left conjunctival sac of the intact eye of four New Zealand White rabbits. Reading times were 1 h, 1, 2, 3, 4 and 7 days post instillation. Within 2 days post instillation the reading of all characteristics (i.e. corneal opacity, iris, conjunctivae redding, chemosis) resulted in maximum scores, which were not reversible within 7 days post application.