Diisononyl adipate

Endpoint summary

Description of key information

Acute oral toxicity (rat): LD50 of >5000 mg/kg bw (BASF, 1984)
Acute inhaltion toxicity (rat): LC50 of > 5.7 mg/L (study performed with the structural analogue diethylhexyl adipate (DEHA)) 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

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

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: male: 218 g; female 188 g
- Fasting period before study: 16 hours
- Diet: ad libitum
- Water : ad libitum
- Acclimation period: at least one week


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

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:

Doses:

single dose of 5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Duration of observation period following administration: 14 days

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality occured.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

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 403 (Acute Inhalation Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.2 (Acute Toxicity (Inhalation))

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1150 (Acute inhalation toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Physical state: liquid
- Analytical purity: 99.7%
- Lot/batch No.: #22513
- Stability under test conditions: The stability of the test substance over the study period
has been proven by reanalysis
- Storage condition of test material: at room temperature

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeding facility Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: approx . 8 - 9 weeks
- Weight at study initiation: 206 gram (females); 284 gram (males)
- Housing:singly in cages type DK III (Becker, Germany).
- Diet: ad libitum
- Water:ad libitum
- Acclimatisation period:at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30-70
- Air changes (per hr): 12/12

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose/head only

Vehicle:

air

Details on inhalation exposure:

Exposure system: Head-nose inhalation system INA 20 (glass-steel construction, BASF Aktiengesellschaft, volume V ~ 55L).
Technical equipment:
piston metering pump KP 2000 (Desaga)
two-component atomizer Mod.970 (stainless steel, Schlick).
aerosol mixing vessel (glass, BASF)
cyclonic separator (glass, BASF).
Flow rate of the test substance to the atomizer: 35.0 ml/h.
Exposure: supply air flow of 1500 L/h, exhaust air flow of 1350 l/h.

Analytical determination method: Gravimetric determination of the inhalation atmosphere concentration.
In addition, particle size was analyzed.
Equipment:
Stack Sampler Mark III (Andersen)
Vacuum Compressed Air Pump (Millipore)
Sampling probe (internal diameter 6.9 mm)
Limiting orifice 3 L/min
Balance: Sartorius M3P and Sartorius LC 1201S.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

5.7 mg/L

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Duration of observation period: 14 days.
Clinical examinations: body weight (prior to exposure, after 7 days and after 14 days). Other clinical signs and findings.
Pathology: gross-pathological examination.

Statistics:

Performance of a Probit analysis.

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 5.7 mg/L air

Exp. duration:

4 h

Mortality:

No lethality occured at the tested concentration of 5.7 mg/L during the study period of 14 days. Therefore, the study satisfied the criteria of a limit test (LC50 > 5.7 mg/L).

Clinical signs:

other: Clinical examination revealed irregular and accelerated respiration as well as attempts to escape and piloerection. No clinical signs could be detected from post dosing day 5 onward.

Body weight:

Body weight development of the animals was not influenced.

Gross pathology:

No macroscopic pathological findings were noted in animals examined at the end of the study.

Other findings:

Particle size distribution, expressed as mass median aerodynamic diameter (MMAD), was calculated to be 1.4 µm.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

5 700 mg/m³ air

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Studies available for diisononyl adipate (DINA):

For the acute oral route a BASF study was chosen as key as reporting describes enough details to consider the study comparable to OECD guidelines for oral toxicity. A single dose of 5000 mg/kg bw were administerd to 5 male and 5 female Wistar rats. The observation period was 14 days. No mortality, clinical or pathological sings were observed. The oral LD50 has been estimated to be >5000 mg/kg bw in male and female rats. (BASF, 1984)

Studies availabe for the structural analogue diethylhexyl adipate (DEHA, Cas: 103 -23 -1):

A well performed inhalation OECD-guideline (accorting to OECD 403) is available on the structural analogue diethylhexyl adipate (DEHA). 5 male and 5 female Wistar rats were exposed to DEHA for 4 hours. (BASF, 1998). Clinical examination revealed irregular and accelerated respiration as well as attempts to escape and piloerection. No clinical signs could be detected from post day 5 anward. Body weight development of the animals was not influenced. No macroscopic pahtological findings were noted in animals examined at the end of the study. The LC50 was > 5.7 mg/L.

Regarding the dermal route of exposure no data were available. However, in accordance with column 2 of REACH Annex VIII-X, no dermal acute toxicity study is required as data for the oral and inhalation route are available.

Justification for classification or non-classification

Based on the available acute oral and inhalation toxicity data, DEHA does not have to be classified for acute toxicity EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.