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Administrative data

Description of key information

The LD50 of the available acute oral and dermal toxicity studies performed with a consitiuent of the registration substance or strucutral analogues, were derived at greater than 2000 mg/kg bw.

-Acute oral toxicity:

tetradecyl myrisitate (CAS No 3234 -85 -3): LD50 > 5000 mg/kg bw

isooctadecal palmitate (CAS No 72576 -80 -8): LD50 > 2000 mg/kg bw

-Acute dermal toxicity:

decyl octadec-9 -enoate (CAS No 3687 -46 -5): LD50 > 2000 mg/kg bw

2 -octyldodecyl isooctadecanoate (CAS No 93803 -87 -3): LD50 > 2000 mg/kg bw

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:
1976
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)
Deviations:
yes
Remarks:
the analytical purity of the test substance is not reported
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 176-296 g
- Fasting period before study: overnight
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50%
- Amount of vehicle (if gavage): 5 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations of mortality and signs of toxicity were made 1, 3, 4, 6 and 24 h after administration and daily thereafter; animals were weighed prior to dosing and prior to necropsy.
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
One male rat died on day 4 after administration. No information on the cause of death was provided.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
No effect on body weight was noted.
Gross pathology:
No substance-related findings were noted during the necropsy.
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 5000 mg/kg bw
Executive summary:

The acute oral LD50 of tetradecyl myristate (CAS No. 3234 -85 -3), a constituent of the registration substance, in rats of both sexes observed over a period of 14 days is > 5000 mg/kg bw.

Based on the result of this study the substance not subject for labelling and classification requirements according to regulatory requirements.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Reliable with restrictions

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
19 May - 2 Jun 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to cread across justification justification setcion 13.2

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to cread across justification justification setcion 13.2

4. DATA MATRIX
Please refer to cread across justification justification setcion 13.2
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality during the study period (see Table 1).
Clinical signs:
Piloerection was observed from 4 h - day 2 after dosing in 2/5 males (see Table 2). Chromodacryorrhoea (excessive secretion of a reddish-brown liquid from the eyes) (grade 1) was observed in 3/5 males 2-4 hours after dosing. No systemic clinical signs of toxicity were observed during the study period in females.
Body weight:
The body weight gains of males and females were within the normal ranges during the study period.
Gross pathology:
The necropsy and histopathological examination did not reveal substance-related findings.
Other findings:
- Other observations: On the treated skin area, erythema was observed for up to 4 days during Day 3-7 in 3/5 females. Scales or scabs (grade 1) were noted on the treated skin area in 5/5 females and 3/5 males for up to 9 days during Day 7-15 of the observation period.

Table 1: Mortality and clinical signs

Dose
[mg/kg bw]

Toxicological results*

Duration of clinical signs

Time of death

Mortality (%)

Males

2000

0/3/5

4 h – day 2 

Day 1-3

0

Females

2000

0/0/5

-

Day 1

0

LD50 > 2000 mg/kg bw

* first number = number of dead animals                                 

second number = number of animals with systemic clinical signs         

  third number = number of animals used                 Table 2: Clinical signs, systemic/local

Effect*

Max grade

Male No./duration (hours or day after dosing)

Female No./duration (hours or day after dosing)

 

 

1

2

3

4

5

6

7

8

9

10

Systemic

 

 

 

 

 

 

 

 

 

 

 

Piloerection

 1

4 h - 2 d

 

 

 

4 h - 2 d

 

 

 

 

 

Chromoda-cryorrhoea

 3

 

2 - 4 h

2 - 4 h

4 h

 

 

 

 

 

 

Local

 

 

 

 

 

 

 

 

 

 

 

Erythema, focal

 4

 

 

 

 

 

7 d

 

7 d

3 – 7 d

7 d

Scales

 3

 

 

8 – 10 d

7 – 15 d

 

7 – 8 d, 14 d

8 – 11 d

7 – 9 d

7 – 8 d

7 – 9 d

Scabs

 3

 

7 - 11 d

 

9 - 15 d

 

8 – 13 d

 

 

 

 

* all grade 1

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 (dermal) of the substance is greater than 2000 mg/kg bw.
Executive summary:

The acute dermal toxicity of decyl octadec-9 -enoate (CAS No 3687-46-5), a strucutral analogue, was assessed in a study according to OECD Guideline 402 with rats. As a result of the study, the LD50 (dermal) was determined to be > 2000 mg/kg bw.

Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
12 - 26 Feb 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Please refer to cread across justification justification setcion 13.2

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Please refer to cread across justification justification setcion 13.2

3. ANALOGUE APPROACH JUSTIFICATION
Please refer to cread across justification justification setcion 13.2

4. DATA MATRIX
Please refer to cread across justification justification setcion 13.2
Reason / purpose for cross-reference:
read-across source
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality during the study period (see Table 1).
Clinical signs:
Red staining of the neck fur (score 1 of 3) was observed in 1/5 females on Day 8-13. This is an effect that is frequently seen in rats under stressful conditions and is therefore not considered to be toxicologically relevant. No other clinical signs were noted in any animals during the study period.
Body weight:
The body weight gains were within the normal ranges in males and females during the whole study period.
Gross pathology:
The necropsy and histopathological examination did not reveal any substance-related findings.

Table 1: mortality and clinical signs

Dose
[mg/kg bw]

Toxicological results*

Duration of clinical signs

Time of death

Mortality (%)

Males

2000

0/0/5

- 

-

0

Females

2000

0/1/5

Day 8-13 

-

0

Overall LD50 > 2000 mg/kg bw

* first number = number of dead animals                                 

 second number = number of animals with systemic clinical signs         

 third number = number of animals used                               

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 of 2-octyldodecyl isooctadecanoate, a structural analogue, in rats of both sexes observed over a period of 14 days is > 2000 mg/kg bw.
Executive summary:

The acute dermal LD50 of 2-octyldodecyl isooctadecanoate (CAS No 93803 -87 -3), a structural analogue, in rats of both sexes observed over a period of 14 days (according to OECD 402) is > 2000 mg/kg bw.

Based on the result of this study the substance is not subject for labelling and classification requirements according to regulatory requirements.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Reliable with restrictions

Additional information

Justification for classification or non-classification

Based on the results obtained the submission substance has not to be classified for acute toxic effects according to Regulation (EC) No. 1272/2008 (CLP).