Registration Dossier

Administrative data

Description of key information

Experimental studies on oral and dermal acute toxicity are available. Dodecanedioic Acid has very low toxicity upon acute exposure.

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
Study period:
1989-02-21 to 1989-03-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ORGANISMS: 
- Strain: Bor: WISW (SPF TNO)
- Source: F. Winkelmann, Borchen (Germany)
- Weight at study initiation:  total mean 113 g
- Controls: no
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
ADMINISTRATION: 
- Preparation of test substance: grinding in mortar, suspension in corn  oil (30 %) with ultra turrax
- Doses per time period: single dose (gavage)
- Volume administered or concentration: 10 ml/kg bw
- Post dose observation period: 14 days
Doses:
3000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
EXAMINATIONS:
- Body weights: before, and 1, 7, 14 days after treatment
- Clinical signs and mortality: within 6 hours after treatment,  thereafter daily
- Necropsy: all animals (macroscopic)
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 000 mg/kg bw
Mortality:
MORTALITY: No deaths occurred
Clinical signs:
CLINICAL SIGNS: 
- 30 minutes after treatment: piloerection and slight sedation in all  animals
- 2 hours after treatment: no more sedation
- 3 hours after treatment: no more signs of toxicity
Body weight:
Body weight gain was not affected.
Gross pathology:
NECROPSY FINDINGS: No evidence of macroscopically discernible organ changes was found.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EC Regulation 1272/2008
Executive summary:

In a acute oral limit test according to TG OECD 401 five rat per sex received a dose of 3000 mg/kg bw. There were no mortalities and no adverse effects other than initial slight sedation and piloerection which subsided after two hours.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
3 000 mg/kg bw
Quality of whole database:
Klimisch 1 (reliable without restrictions)

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment, however only summary available, no GLP
Principles of method if other than guideline:
see Test Conditions
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
other: albino rabbits
Sex:
male
Details on test animals and environmental conditions:
TEST ORGANISMS: 
- Strain: unspecified albino
- Weight at study initiation: 2.9-3.2 kg, mean 2.959 kg
- Controls: no
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
ADMINISTRATION: 
- Area covered: trunk area (back) clipped free of hair; plastic collars
- Preparation of test substance: moistened with physiological saline
- Occlusion: Three 3" x 3" 12 ply gauze pads; under wrap plus gauze  bandage; fixed with adhesive bandage
- Removal of test substance: 24 hours after administration washing with  water and drying
Duration of exposure:
24 hours
Doses:
6000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
not specified
Details on study design:
EXAMINATIONS: 14-day recovery period
OTHER: The dose was based on a range finding study with 1 rabbit each  dosed 5000 or 7500 mg/kg bw. There was difficulty adhering
7500 mg/kg bw  to the rabbit's back. Both rabbits survived.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 6 000 mg/kg bw
Mortality:
MORTALITY: No animal died during the study
Clinical signs:
CLINICAL SIGNS: slight skin irritation, diarrhea and nasal discharge. Two  rabbits had weight loss on the day after dosing and there was sporadic 
 weight loss 3-13 days after dosing. .
Body weight:
The mean body weight increased from  2.959 to 3.353 kg
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EC Regulation 1272/2008
Conclusions:
no classification regarding acute dermal toxicity required
Executive summary:

In a limit test on dermal toxicity six male albino rabbits received a dose of 6000 mg/kg bw applied to the back skin for 24 hours. No mortalities occurred and observed effects included slight skin irritation, diarrhea, nasal discharge and sporadic weight loss.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
6 000 mg/kg bw
Quality of whole database:
Klimisch 2 (reliable with restrictions)

Additional information

Dodecanedioic Acid has very low toxicity by the oral or dermal route.

No data on acute toxicity upon inhalation are available. However, since the vapour pressure of dodecanedioic acid is very low (1.5 x 10E-8 Pa) exposure via the inhalation route is predicted to be not relevant and a study on inhalation toxicity can be waived. .

Justification for classification or non-classification

Dodecanedioic Acid has very low toxicity by the oral or dermal route LD50 exceeding limit values. Inhalation is not relevant because of low vapour pressure. Therefore classification regarding acute toxicity is not warranted.