Tridecanedioic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-09-03 to 2012-09-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

(2001)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Version / remarks:

(2008)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Version / remarks:

(2002)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tridecanedioic acid

EC Number:

208-011-4

EC Name:

Tridecanedioic acid

Cas Number:

505-52-2

Molecular formula:

C13H24O4

IUPAC Name:

tridecanedioic acid

Constituent 2

Reference substance name:

Brassylic acid

IUPAC Name:

Brassylic acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Brassylic acid/Tridecanedioic acid
- Physical state:White powder
- Analytical purity: 99.42 %
- Lot/batch No.:3311050098 of 22 August 2011
- Expiration date of the lot/batch:27 Jun 2013
- Storage condition of test material: At room temperature

Test animals

Species:

rat

Strain:

other: CD / Crl: CD(SD)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at start of administration: Approx. 8 weeks
- Weight at start of administration: 164 - 183 g
- Fasting period before study:
- Housing: During the 14-day observation period the animals were kept in groups of 3 animals in MAKROLON cages (type III plus). Granulated textured wood was used as bedding material for the cages.
- Diet:Commercial diet, ssniff® R/M-H V1534 (Certificates of analysis provided) ; discontinued approx. 16 hours before administration
- Water: tap water ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 12 to 18-fold air change per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light (about 150 lux at approx. 1.50 m room height)


IN-LIFE DATES: From: August 21, 2012 To:September 18, 2012

IN-LIFE DATES: From: August 21, 2012; To:September 18, 2012

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.8% aqueous hydroxypropylmethylcellulose

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Lot/batch no. (if required): 11 A 27-N27


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: A limit test at one dose level of 2000 mg/kg bw was carried out on 6 female animals

Doses:

2000 mg/kg bw (limit test)

No. of animals per sex per dose:

6 female animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Observations were performed before and immediately, 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. All surviving animals were observed for a period of 14 days. Individual body weights were recorded before administration of the testsubstance and thereafter in weekly intervals up to the end of the study.

- Necropsy of survivors performed: yes (all animals)

- Other examinations performed: changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory,autonomic and central nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Any tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma were also noted.

Statistics:

No statistical analysis was performed as the method used is not intended to allow a calculation of a precise LD50 value.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: 24 hrs and 14 days

Mortality:

No death was recorded within the test period.

Clinical signs:

other: No clinical signs were noted.

Gross pathology:

No pathological changes were observed at necropsy.

Other findings:

- Histopathology:
No histopathology was carried out as no macroscopical findings were noted at autopsy.

Any other information on results incl. tables

Study report attachment:

LPT 28719 (Table 3 Bodyweights)

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In this acute oral toxicity study in rats (limit test), the LD 50 (females) for Brassylic acid was > 2000 mg/kg bw.

Executive summary:

In an acute oral toxicity study, 6 female rats (CD/Crl: CD(SD) were given a single oral dose of Brassylci acid in 0.8% aqueous hydroxypropylmethylcellulose by gavage at a dose of 2000 mg/kg bw.

Animals were then observed for 14 days. There were no deaths and no treatment-related clinical signs, necropsy findings or changes in body weight during the study.

Oral LD50 Females = > 2000 mg/kg bw (Limit test with no mortalities)