2-decyltetradecanoic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04.02.2015 - 18.02.2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-decyltetradecanoic acid

EC Number:

298-190-5

EC Name:

2-decyltetradecanoic acid

Cas Number:

93778-52-0

Molecular formula:

C24H48O2

IUPAC Name:

2-decyltetradecanoic acid

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Isocarb 24
- Substance type: Product
- Lot/batch No.: ISC2403, 04058/MA
- Physical state: crystalline at ambient conditions

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: males: 09 -10 weeks old; females: 12 -13 weeks old
- Weight at study initiation:237 - 244 g (males); 217 - 227 g (females)
- Housing: The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 1239)
- Diet (e.g. ad libitum): Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 02102140831)
- Water (e.g. ad libitum): Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 ° C
- Humidity (%): 45 -65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: 2015-01-29 To: 2015-02-18

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

other: Aqua ad injectionem (AlleMan Pharma, lot no. 260813_1, expiry date: 31 July 2016)

Details on dermal exposure:

TEST SITE
- Area of exposure: uniformly over an area
- % coverage: 10
- Type of wrap if used: The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, at the end of the exposure period the residual test item was removed using aqua ad injectionem
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- For solids, paste formed: in order to ensure good skin contact, the test item was moistened with the vehicle.

VEHICLE
- Lot/batch no. (if required): 260813_1,

Duration of exposure:

24 hours

Doses:

2000 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 for mortality and clinical/behavioral signs of toxicity were made at least three times on the day of dosing (day 0) and at least once daily thereafter.
- Necropsy of survivors performed: yes, at the end of the observation period the all animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally (Narcoren® Merial; lot no.: 236014; expiry date: 31 January 2016) at a dosage of 250-400 mg/kg bw.
- Other examinations performed: Individual body weights were recorded just prior to dosing and on days 1; 8 and 15. Observations for evidence of dermal irritation were made all days.

Individual reactions of each animal were recorded at each time of observation.
Toxic response data were recorded by sex and dose level.
Nature, severity and duration of clinical observations were described.
The body weight changes were summarised in a tabular form.
Necropsy findings were described.
With few exceptions, data were captured using the validated departmental computerized system E-WorkBook (version 9.4.0, ID Business Solutions Ltd.).

Statistics:

not performed

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortality occurred

Clinical signs:

other: The test item showed no signs of acute dermal toxicity and no signs of dermal irritation after a single dose application.

Gross pathology:

With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 was greater than 2000 mg/kg bodyweight in male and female rats.

Executive summary:

Under the conditions of the present study, single dermal application of the test item 2 -decyltetradecanoic acid to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity nor signs of irritation. The dermal LD50 was determined to be > 2000 mg 2 -decyltetradecanoic acid / kg body weight.