Diisononyl adipate

Endpoint summary

Description of key information

Skin irritation: not irritating (BASF, 1983)
Eye irritation: not irritating (BASF, 1983)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

no

Specific details on test material used for the study:

purity: >99% (GC)
test substance name: Di-iso-nonyladipat
Charge: 14626

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach / Main, Germany
- Age at study initiation: no data
- Weight at study initiation: male: 2.70 kg; females (mean): 2.22 kg
- Housing: stainless steel, wire mesh walk floors, floor area 40 cm x 51 cm
- Diet: Ovator Solikanin 4 mm, about 130 g per animal per day
- Water: about 250 ml tap water per animal per day
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 h

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

about 0.5 ml

Duration of treatment / exposure:

4 hours

Observation period:

72 h after beginning of application

Number of animals:

3 (1 male, 2 females)

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: no data
- Type of wrap if used: a porous dressing :four layers absorbed gauze and porous bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hours

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4-72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 4-72 h

Score:

0

Max. score:

4

Interpretation of results:

GHS criteria not met

Executive summary:

Three Vienna White rabbits were applied the undiluted test substance for 4 hours in accordance with OECD guideline 404. The test substance was not a skin irritant as the mean score was 0 for both erythema and edema.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Specific details on test material used for the study:

purity: >99% (GC)
test substance name: Di-iso-nonyladipat
Charge: 14626

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach / Main, Germany
- Age at study initiation: no data
- Weight at study initiation: male: 2.79 kg; females (mean): 3.28 kg
- Housing: individual
- Diet: Ovator Solikanin 4 mm, about 130 g per animal per day
- Water: about 250 ml tap water per animal per day
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12 h

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml

Duration of treatment / exposure:

Single application to the conjuctival sac of the eyelid; the substance is not washed out.

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3 (1 male, 2 females)

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1-72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1-72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1-72 h

Score:

0.83

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1-72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Primary irritation index equals 1

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation: In an skin irritation test (according to the OECD guideline 404) diisononyl adipate was tested using 3 rabbits (Vienna white). The unchanged test substance was applicated for 4 hours. No skin irritation was noted (no erythemal and no oedema; mean scores of 0 for all time points). The test substance is not irritating to skin (BASF, 1983).

Eye irritation:In an eye irritation test (according to the OECD guideline 405) diisononyl adipate was tested using 3 rabbits (Vienna white). The unchanged test substane was applicated to the conjunctival sac of the eyelid. The substance is not washed out. A slight redness of the conjunctiva was noted (mean score of 1 at 24 hours only) in the eye irritation test. The test substance ist not irritating to eye.

The structural analogue diethylhexyl adipate (DEHA, Cas: 103 -23 -1) is also not irritating to skin and eyes.

Justification for classification or non-classification

Findings do not meet the critera for classification as eye irritant or as a skin irritant according EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.