Amines, bis(hydrogenated tallow alkyl), 2-[[bis(hydrogenated tallow alkyl)amino]carbonyl]benzoates

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 days

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Modern GLP study conducted in accordance with modern guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Animals were caged in groups (by sex) during the post-dosing observation period

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

Animals were caged in groups (by sex) during the post-dosing observation period

GLP compliance:

yes (incl. QA statement)

Test type:

other:

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Amines, bis(hydrogenated tallow alkyl), 2-[[bis(hydrogenated tallow alkyl)amino]carbonyl]benzoates

EC Number:

294-705-2

EC Name:

Amines, bis(hydrogenated tallow alkyl), 2-[[bis(hydrogenated tallow alkyl)amino]carbonyl]benzoates

Cas Number:

91745-35-6

Molecular formula:

C72H140N2O3-C80H156N2O3

IUPAC Name:

Amines, bis(hydrogenated tallow alkyl), 2-[[bis(hydrogenated tallow alkyl)amino]carbonyl]benzoates

Details on test material:

Batch number: E0011-039E

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, UK
- Age at study initiation: 8–12 weeks
- Weight at study initiation: At least 200g. Weight variation did not exceed +/- 20% of the mean weight for each sex.
- Fasting period before study: No.
- Housing: Suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum): Yes.
- Water (e.g. ad libitum): Yes.
- Acclimation period: At least five days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19–25
- Humidity (%): 30–70
- Air changes (per hr): At least 15
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: 31/01/08 To: 14/02/08

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

arachis oil

Details on dermal exposure:

TEST SITE
- Area of exposure: Back and flanks
- % coverage: Approximately 10%
- Type of wrap if used: Surgical gauze semi-occluded with a piece of self-adhesive bandage.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treated skin and surrounding hair wiped with cotton wool moistened with distilled water.
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2,000 mg/kg bodyweight
- Concentration (if solution): N/A
- Constant volume or concentration used: no.
- For solids, paste formed: Not stated, but test material was moistened with arachis oil


VEHICLE Test material was moistened with arachis oil BP
- Amount(s) applied (volume or weight with unit): Unknown
- Concentration (if solution): Not applicable.
- Lot/batch no. (if required): Unknown.
- Purity: Unknown.

Duration of exposure:

24 hours

Doses:

2,000 mg/kg bodyweight

No. of animals per sex per dose:

Five

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations : Observations were made at 0.5, 1, 2 and 4 hours after test material application and daily thereafter.
- Frequency of weighings: Bodyweights were measured prior to test material application (Day 0) and on Days 7 and 14.
- Necropsy of survivors performed: yes

Statistics:

The LD50 was estimated.

Results and discussion

Effect levels

Remarks on result:

other: There were no deaths

Mortality:

No mortality occurred.

Clinical signs:

No clinical signs of toxicity were oberved.

Body weight:

No effects on bodyweight gain were oberved.

Gross pathology:

No gross pathology was observed.

Other findings:

No indications of dermal irritation were observed.

Applicant's summary and conclusion

Conclusions:

The test material caused no mortality or signs of toxicity in this study. The acute dermal LD50 of the test material in Sprague-Dawley CD rats is greater than 2,000 mg/kg bodyweight.

Executive summary:

An acute dermal toxcity study (limit test) was conducted in Sprague-Dawley CD rats using a dose of 2,000 mg of test material (moistened with arachis oil BP) per kg bodyweight, applied under semi-occlusive dressing for 24 hours and followed by a 14 -day observation period. This GLP study was conducted in accordance with OECD Test Guideline 402, except that, following removal of the test material, animals were group-housed (by sex), but this is not considered to have affected study reliability.

No animals died during the study and no signs of toxicity or adverse effects were observed in-life or at necropsy. The LD50 of the test material in Sprague-Dawley rats is concluded to be >2,000 mg/kg bodyweight.