Registration Dossier

Administrative data

Description of key information

Oral (similar to OECD 401): LD50 rat, mouse > 5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
13 Mar 1991 - 13 Mar 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
No purity of test substance reported. Observation period only 7 days after treatment.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1987
Deviations:
yes
Remarks:
No purity of test substance reported. Observation period only 7 days after treatment
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
mouse
Strain:
NMRI
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 19 to 20 g

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5.7 mL/kg
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of weighing: on day of treatment and last day of observation
- Frequency of observations: once daily
Key result
Sex:
female
Dose descriptor:
LD50
Remarks:
mouse
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
No abnormal clinical signs and no abnormal behaviour occured.
Body weight:
All 5 female mice showed a gain in body weight (gain of 7.5 - 8g per mouse over a period of 7 days).
Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
No purity of test substance reported.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
Principles of method if other than guideline:
Study was conducted prior to adoption of any OECD guideline.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Fasting period before study: yes, 20-24 h
- Housing: 2-5 per cage
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test material was administered as supplied by the sponsor.
Doses:
Preliminary test: 1000, 5000, 10000 mg/kg bw
Main test: 10000, 15000, 20000 mg/kg bw
No. of animals per sex per dose:
Preliminary test: 2 at 1000 mg/kg bw, 1 at 5000 and 1 at 10000 mg/kg bw
Main test: 5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
Probit method
Preliminary study:
2m+2f animals at 1000 mg/kg: no mortality
1m+1f animal at 5000 mg/kg: no mortality
1m+1f animal at 10000 mg/kg: no mortality
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
rat
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD50
Remarks:
rat
Effect level:
16 025 mg/kg bw
Based on:
test mat.
Remarks:
Calculated using Probit method
95% CL:
> 12 973 - < 19 795
Remarks on result:
other:
Remarks:
5 out of 10 animals were dead after 14d observation period after single oral dosing at 15000 mg/kg
Mortality:
1 out of 10 rats was found dead after dosing at 10000 mg/kg. No mortality was seen in the preliminary study.

Dose
mg/kg

Gender

Total number of rats

Number of dead rats after 14 day observation period

% mortality

1000

m

2

0

0

1000

f

2

0

0

5000

m

1

0

0

5000

f

1

0

0

10000

m

1

0

0

10000

f

1

0

0

10000

m

5

1

10

10000

f

5

0

0

15000

m

5

4

80

15000

f

5

1

20

20000

m

5

4

80

20000

f

4

2

50

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises adequate and reliable studies (Klimisch score 2). The selected studies are sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute oral toxicity

The acute oral toxicity of Propylene dinonanoate (CAS 41395-83-9) was assessed in two studies conducted similar to OECD guideline 401. Single administration of 10, 15 and 20 g/kg bw to 5 rats per sex via oral gavage resulted in mortality of one animal at 10000 mg/kg bw (key study, 1977). The LD50 was calculated to be 16025 mg/kg bw in rats. Single administration of 5000 mg/kg bw to 5 female mice via oral gavage did not cause mortality (supporting study, 1991). No abnormal clinical signs and no abnormal behaviour occurred during the 7-day observation period.

Overall conclusion for acute toxicity

The available data indicate a very low level of acute toxicity following the oral route and thus Propylene dinonanoate (CAS 41395-83-9) is not considered to be hazardous following acute oral exposure.

Justification for classification or non-classification

CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.