Sebacic acid, compound with hexane-1,6-diamine (1:1)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Data on purity are lacking, but as there was no strong irritation observed, this is thought not to impair the evaluation of the eye irritation potential significantly. As a 50% aqueous preparation is the limit of solubility, no higher concentrations would have been achieved if neat AH salt had been tested and this deviation from the test guideline is thought not to impair the evaluation of the eye irritation potential significantly

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1956

Report date:

1956

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

limited documentation, 50 µl instead of 100 µl test substance instilled

Principles of method if other than guideline:

Not applicable.

GLP compliance:

no

Remarks:

pre-GLP study

Test material

Test material information

Constituent 1

Reference substance name:

Adipic acid, compound with hexane-1,6-diamine (1:1)

EC Number:

222-037-3

EC Name:

Adipic acid, compound with hexane-1,6-diamine (1:1)

Cas Number:

3323-53-3

IUPAC Name:

hexanedioic acid - hexane-1,6-diamine (1:1)

Constituent 2

Reference substance name:

Adipic acid, compound with hexane-1,6-diamine

IUPAC Name:

Adipic acid, compound with hexane-1,6-diamine

Test material form:

other: dry

Details on test material:

- Name of test material (as cited in study report): AH-Salz trocken (hexamethylenediamine adipate, dry)
No further data.
The justification of the read-accross is fully detailed in the endpoint summary.

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Breeder
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12h/12h

Test system

Vehicle:

water

Controls:

other: other eye of the same animals: treated with physiol. saline

Amount / concentration applied:

TEST MATERIAL
- Concentration (if solution): 50%

Duration of treatment / exposure:

instillation once without rinsing

Observation period (in vivo):

10 minutes, and 1, 3 and 24 hours

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- The eye was left unwashed.
SCORING SYSTEM:
- Descriptive scores of the raw data have been converted to Draize numerical scores.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

n = 2

Time point:

other: 24 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

n = 2

Time point:

other: 24 h

Score:

0

Max. score:

2

Reversibility:

other: no effects

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

n = 2

Time point:

other: 24 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: after 10 min and 1 to 3 hours mean score of 1

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

n = 2

Time point:

other: 24 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Irritant / corrosive response data:

Until 3 hours after administration of the test substance, very slight (equivalent to Draize score 0) and transient conjunctivitis was observed in both tested animals. All effects were completely reversible at 24 hours after instillation (no effects were observed in the control eyes treated with physiological saline).

Other effects:

No data

Any other information on results incl. tables

Limited documentation; no further details.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions of this study, the test item is considered as not irritating to eyes. Thus, no classification is required according to EU criteria.

Executive summary:

In a primary eye irritation study (BASF, 1956), a 50% aqueous preparation of AH salt (limit of solubility) was instilled without rinsing into one eye of each of 2 rabbits (strain and sex not given). The eyes of 2 rabbits were examined 10 minutes, and 1, 3, and 24 hours after instillation of a 50% aqueous solution of the test substance into the right eye. The other eye served as control and was treated with physiological saline. The test material caused slight and transient conjunctivitis in two rabbits after exposure up to 3 hours. All effects were completely reversible within 24 hours.

A very slight and transient conjunctivitis was observed within the first 3 hours in both test animals. All eyes were normal at the 24 -hour reading. Therefore no readings were necessary to be done at 48 and 72 hours as required by the guideline.

As there were only very slight reactions after 3 hours and as no signs of irritation were observed after 24 hours, the test substance can be assumed to have no eye irritating properties.

Based on these results, the test item is considered as not irritating to eyes.

Thus, by analogy, no classification is required for sebacic acid, compound with hexane-1,6 -diamine (1:1), according to the Regulation (EC) 1272/2008 and the Directive 67/548/EEC criteria.