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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1964
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
See attachment

2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL
See attachment
Cross-reference
Reason / purpose for cross-reference:
read-across: supporting information
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
See attachment

2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL
See attachment
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1964
Report date:
1964

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Thirty young adult rats were distributed into three dosage groups of each ten rats and exposed to various dosages of test material administered by intragastric intubation.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetradecyl lactate
EC Number:
215-350-1
EC Name:
Tetradecyl lactate
Cas Number:
1323-03-1
Molecular formula:
C17H34O3
IUPAC Name:
tetradecyl 2-hydroxypropanoate
Constituent 2
Chemical structure
Reference substance name:
Tetradecanol
EC Number:
204-000-3
EC Name:
Tetradecanol
Cas Number:
112-72-1
Molecular formula:
C14H30O
IUPAC Name:
tetradecan-1-ol
Constituent 3
Chemical structure
Reference substance name:
Propanoic acid, 2-hydroxy-, tetradecyl ester with dimers
Molecular formula:
C20H38O5
IUPAC Name:
Propanoic acid, 2-hydroxy-, tetradecyl ester with dimers
Constituent 4
Chemical structure
Reference substance name:
Propanoic acid, 2-hydroxy-, tetradecyl ester with trimers
Molecular formula:
C23H42O7
IUPAC Name:
Propanoic acid, 2-hydroxy-, tetradecyl ester with trimers
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Holtzman
Sex:
female
Details on test animals or test system and environmental conditions:
Type: young adult albino rats
Housing: in mesh bottom cages and fasted 24 h prior to dosing

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Remarks:
yelow liquid
Details on oral exposure:
No further details.
Doses:
0.5, 10, 20 ml/kg bw.
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
The rats received food and water ad libitum after dosage and were observed daily for 14 days following administration.
Statistics:
The LD50 was calculated according to the method of Miller and Tainter (Proc. Soc. Biol. Med. 57, 261, 1944)

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 20 mL/kg bw
Based on:
test mat.
Mortality:
Dosage Animals Number of deaths daily day 14
mL/kg dosed 1 2 3 4 5 6 7 8 9 10 11 12 13 14 % Mortality
2.5 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
5.0 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
10.0 5 0 0 0 1 0 0 0 0 0 0 0 0 0 0 20
20.0 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
40.0 5 0 0 0 1 0 1 1 0 1 0 0 0 0 0 80

Clinical signs:
No details.
Body weight:
Rats were weighing between 200-300 grams, no effects recorded on body weights.
Gross pathology:
No details.
Other findings:
No details.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of Reaction products of tetradecan-1-ol and L-(+)-lactic acid for rats is more than 10 times higher than the maximum limit for classification of 2000 mg/kg bw .