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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The short exposure time of 15 minutes is thought not to impair the evaluation of the skin 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 skin irritation potential significantly.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1956

Report date:

1956

Materials and methods

Principles of method if other than guideline:

Before OECD Guideline 404 was established in 1982, skin irritation was tested using an internal method (BASF test). White Vienna rabbits were used. 2 animals were treated for 1, 5 and 15 minutes using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the liquid test substance on a patch. After the application time of 1, 5, and 15 minutes, respectively, the skin was first washed with undiluted Lutrol 9, then with an aqueous Lutrol solution (50 %). The skin of the animals that had been treated with the test substance for 20 hours, remained unwashed.

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

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

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system 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

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

other: not treated skin

Amount / concentration applied:

TEST MATERIAL
- Concentration (if solution): 50%; saturated solution; pH = 7.5

Duration of treatment / exposure:

1, 5 and 15 minutes

Observation period:

no data

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: back, an application site of 2.5 X 2.5 cm was covered with the liquid (37°C; approx. 1 ml)

REMOVAL OF TEST SUBSTANCE
- Washing: yes, the sites were wiped with a mixture of acetic acid and polyethylene glycol (Lutrol) after the end of the exposure period.

SCORING
Descriptive scores of the raw data have been converted to Draize numerical scores.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

n = 2

Time point:

other: unspecified

Score:

0

Max. score:

4

Reversibility:

other: no effects

Remarks on result:

other: short-time test with 1; 5; 15 min exposure

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

n = 2

Time point:

other: unspecified

Score:

0

Max. score:

4

Reversibility:

other: no effects

Remarks on result:

other: short-time test with 1; 5; 15 min exposure

Irritant / corrosive response data:

None of two animals showed any effects of irritation at any application site.

Any other information on results incl. tables

primary dermal irritation index (PDII), mean of n=2: Score = 0

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 the skin.

Executive summary:

In a skin irritation study (BASF, 1956), application of a saturated aqueous solution of the test substance (concentration ca. 50%) to the back of two rabbits for up to 15 minutes did not produce any signs of irritation. The short exposure time of 15 minutes is thought not to impair the evaluation of the skin 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 skin irritation potential significantly.

The primary dermal irritation index (PDII), mean of n=2: Score = 0. Based on these results, the test substance is considered as not irritating to the skin.

By analogy, sebacic acid, compound with hexane-1,6 -diamine (1:1) is not classified according to the CLP regulation 1272/2008/EC and the Directive 67/548/EC criteria.