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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24/1/1996 to 7/2/1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
tridecyl 2-hydroxybenzoate
EC Number:
947-975-7
Molecular formula:
C20H32O3
IUPAC Name:
tridecyl 2-hydroxybenzoate

Test animals

Species:
rat
Strain:
other: Albino
Sex:
male/female
Details on test animals or test system and environmental conditions:
5 male, 5 female, 222 - 275 g each.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
corn oil
Doses:
Each animal received a single oral dose of the test article at a dose level of five (5) grams per kilogram body weight.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Ten (5M:5F) albino rats, 222 – 275 g, each received a single oral dose of the test article at a dose level of five (5) grams per kilogram body weight. Animals were observed for pharmacological activity and drug toxicity 1, 3, 6 and 24 hours after treatment, and daily thereafter for a total of 14 days. All animals survived the 14 day observation period and were then subjected to a gross necropsy, with all findings noted. The test article was used as a ten (10) percent dilution in corn oil (Sp.g. = 0.91).

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
0

Any other information on results incl. tables

Dose level sex No. Dead/No. Dosed Mortality
g/kg (M:F) (%)
5.0 5M:5F 0/5:0/5 0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to Federal Hazardous Substances Act Regulations, (16 CFR 1500.3), and under the conditions of this test, this test article is not orally toxic to rats.
Executive summary:

Ten (5M:5F) albino rats, 222 – 275 g, each received a single oral dose of the test article at a dose level of five (5) grams per kilogram body weight. Animals were observed for pharmacological activity and drug toxicity 1, 3, 6 and 24 hours after treatment, and daily thereafter for a total of 14 days. All animals survived the 14 day observation period and were then subjected to a gross necropsy, with all findings noted. The test article was used as a ten (10) percent dilution in corn oil (Sp.g. = 0.91).

According to Federal Hazardous Substances Act Regulations, (16 CFR 1500.3), and under the conditions of this test, this test article is not orally toxic to rats.