[No public or meaningful name is available]

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8 September 2006 to 14 November 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

1

Reference substance name:

-

EC Number:

482-480-5

EC Name:

-

Cas Number:

1187571-02-3

Molecular formula:

(R2C5H4NO2)(0-3)(R3C3H5O3)(0-3)H(0-2)B

IUPAC Name:

Coconut oil reaction products with boric acid and diethanolamine

Test animals

Species:

rat

Strain:

other: HanRcc:WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test system
Number of animals per group: 5 males and 5 females
Total number of animals: 5 males and 5 females
Age when treated:
Males - 8 weeks
Females - 11 weeks
Identification: By unique cage number and corresponding color-coded spots on the tail. The animals were marked at acclimatization start.
Randomization: Selected by hand at time of delivery. No computer generated randomization program.
Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.

Environmental conditions
Conditions: Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with ranges for room temperature 22 ± 3 °C and for relative humidity between 30-70 % (values above 70 % during cleaning process possible), automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.

Accommodation: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding during treatment and observation.

Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, ad libitum.

Water Community tap water from Füllinsdorf ad libitum.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

One day before treatment, the backs of the animals were clipped with an electric clipper,
exposing an area of approximately 10 % of the total body surface.

Only those animals without injury or irritation on the skin were used in the test.

On test day 1, the test item was applied at a dose of 2000 mg/kg body weight evenly on the
intact skin with a syringe and covered with a semi-occlusive dressing. The dressing was
wrapped around the abdomen and fixed with an elastic adhesive bandage.

Application volume/kg body weight: 2.11 mL

Duration of exposure:

Twenty-four hours after the application the dressing was removed and the skin was flushed
with lukewarm tap water and dried with disposable paper towels. Thereafter, the reaction
sites were assessed.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5 females / 5 males

Details on study design:

Observations:
Mortality / Viability Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15.

Body weights: On test days 1 (prior to administration), 8 and 15.

Clinical signs: Daily during the acclimatization period, during the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1. Once daily during days 2-15.
Local signs Once daily during days 2-15. All abnormalities were recorded.

Necropsy:
All animals were killed at the end of the observation period by Carbon dioxide asphyxiation
and discarded after macroscopic examinations were performed. No organs or tissues were
retained.

Statistics:

No statistical analysis was used.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths occurred during the study.

Clinical signs:

other: Slight erythema was observed in all animals on test day 2 and persisted in three males and three females until test day 3, 4 or 7, respectively. Scaling was noted, in three females on test day 4 and persisted in two animals until test day 7, and in three

Gross pathology:

No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an OECD 402 study the LD50 (rat) was determined to be greater than 2000 mg/kg body weight.

Executive summary:

Five male and five female HanRcc:WIST (SPF) rats were treated with the test substance at 2000 mg/kg by dermal application. The test item was applied undiluted as delivered from the sponsor at a volume dosage of 2.11 mL/kg. The application period was 24 hours.

The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Local signs were noted once daily from test day 2 to 15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.

No deaths occurred during the study.

Slight erythema was observed in all animals on test day 2 and persisted in three males and three females until test day 3, 4 or 7, respectively. Scaling was noted, in three females on test day 4 and persisted in two animals until test day 7, and in three males from test day 4 to 7 persisting in two animals until test day 10 and 11, respectively. Slight crusts were noted in one animal from test day 8 to 10.

The body weight of the animals was within the range commonly recorded for this strain and age.

No macroscopic findings were observed at necropsy.

 

The LD50 (rat) was determined to be greater than 2000 mg/kg body weight.