Tridecanedioic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-09-03 to 2012-09-17

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 402 (Acute Dermal Toxicity)

Version / remarks:

(1987)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

(2008)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

(1998)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute 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:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories Research Models and Services, 97633 Sulzfeld Germany
- Age at dosing : approximately 8 weeks (males/females)
- Weight at dosing: Males: 216 - 226 g; Females: 205 - 216 g
- Fasting period before study:
- Housing: Animals were kept singly 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 17, 2012

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: Aqua ad iniectabilia (water for injection)

Details on dermal exposure:

TEST SITE
- Area of exposure: shaved intact dorsal skin; the site was situated on the animal's back between the fore and hind extremities
- % coverage: 5 cm x 6 cm, approx. 1/10 of body surface
- Type of wrap if used: Eight layers of gauze covered with a plastic sheet and secured with adhesive plaster strips (Omniplast (P. HARTMANN AG), Germany)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing
- Time after start of exposure: the occlusive test patch was removed after 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 g Brassylic acid were moistened with 1 g aqua ad iniectabilia; 3 g/kg was applied per animal

VEHICLE
- Lot/batch no. (if required): 121378141 (B. Braun Melsungen AG, 34212 Melsungen, Germany )

Duration of exposure:

24 hrs

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

10 animals (5 males and 5 females)

Control animals:

not specified

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 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. Observations on mortality were made at least once daily.

- 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.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: 24 hrs and 14 days

Mortality:

There were no deaths during the study.

Clinical signs:

other: There were no clinical signs of toxicity.

Gross pathology:

The macroscopic examination did not reveal any changes.

Other findings:

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

- Other observations:
No skin reactions were observed at the application site.
No influence on animal behaviour was noted.

Any other information on results incl. tables

Study report attachment:

LPT 28720 (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 dermal toxicity study in rats (limit test), the LD 50 (males/females) for Brassylic acid was > 2000 mg/kg bw.

Executive summary:

In an acute dermal toxicity study, groups of young adult CD/Crl: CD(SD) rats (5/sex) were dermally exposed (occlusive) to Brassylic acid in water for injection for 24 hours to 1/10 of the body surface at a dose of 2000 mg/kg bw. Animals then were observed for 14 days.

There were no deaths during the study and no treatment related clinical signs, necropsy findings, changes in body weight or animal behaviour were observed. No skin reactions were observed at the application site.

Dermal LD50 Male/Female = > 2000 mg/kg bw (Limit test, no mortalities)