2-tetradecyloxirane, reaction products with boric acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-08-08 to 2012-08-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

Not applicable

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-tetradecyloxirane, reaction products with boric acid

EC Number:

701-392-2

IUPAC Name:

2-tetradecyloxirane, reaction products with boric acid

Test material form:

not specified

Details on test material:

- Physical state: Waxy off-white solid
- Analytical purity: 100 %
- Date of receipt: 2012-07-02
- Expiration date of the lot/batch: Not supplied
- Storage condition of test material: Room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8 to 12 Weeks
- Weight at study initiation: 200 g
- Fasting period before study: None
- Housing: Suspended solid floor polypropylene cages furnished with woodflakes.
- Water: Mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70 %
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light/dark cycle

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Back and flanks
- % coverage: ca. 10% of the total body surface area
- Type of wrap if used: Self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Cotton wool moistened with arachis oil BP to remove any residual test item.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): N/A
- Constant volume or concentration used: yes
- For solids, paste formed: N/A

VEHICLE
- Amount(s) applied (volume or weight with unit):N/A
- Concentration (if solution):N/A
- Lot/batch no. (if required): N/A
- Purity: N/A

Duration of exposure:

24 h

Doses:

Single dose level of 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for deaths or overt signs of toxicity ½, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Animals were weighed on Days 0, 7 and 14
- Necropsy of survivors performed: Yes, At the end of the study the animals were killed by cervical dislocation.
- Other examinations performed: Clinical signs, body weight, dermal reaction

Statistics:

Using the mortality data obtained, an estimate of the acute dermal median lethal dose (LD50) of the test material was made.

Results and discussion

Preliminary study:

Not applicable.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: no mortality was observed.

Mortality:

No mortality was observed.

Clinical signs:

other: There were no signs of systemic toxicity.

Gross pathology:

No abnormalities were noted at necropsy

Other findings:

- Organ weights: No data available
- Histopathology: No data available
- Potential target organs: No data available
- Other observations: No data available

Any other information on results incl. tables

Table1: Individual bodyweights and weekly bodyweight changes

Dose level (mg/kg bw)	Animal no. and sex	Body weight (g) at Day			Body weight (g) during Week
		0	7	14	1	2
2000	1-0 M	336	343	365	7	22
	1-1 M	318	333	358	15	25
	1-2 M	315	323	335	8	12
	1-3 M	295	311	325	16	14
	1-4 M	336	345	368	9	23
	2-0 F	216	220	214	4	-6
	2-1 F	230	235	236	5	1
	2-2 F	228	229	236	1	7
	2-3 F	224	226	228	2	2
	2-4 F	220	220	226	0	6

Table 2: Dermal irritation observations

 

Animal Number	Observation	Day
		1	2	3	4	5	6	7	8	9	10	11	12	13	14
Male 1-0	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Other	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Male 1-1	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Other	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Male 1-2	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Other	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Male 1-3	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Other	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Male 1-4	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Other	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Female 2-0	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Other	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Female 2-1	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Other	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Female 2-2	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Other	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Female 2-3	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Other	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Female 2-4	Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Oedema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	Other	0	0	0	0	0	0	0	0	0	0	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, the acute dermal LD50 of test item is higher than 2000 mg/kg bw in rats therefore it is not classified according to CLP Regulation (EC) N° (1272-2008).

Executive summary:

Test Guidance

Performed according to OECD Guideline 402

Method and materials

A group of Wistar (RccHan:WIST) rats (5/sex/dose) was given a single dermal application of test item at 2000 mg/kg bw. The test item was placed directly on back and flanks of the skin representing approximately 10 % of the total body surface of the animals. The test site was then covered by a semiocclusive dressing for 24 hours. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.

Results

No mortality and no clinical signs were observed during the study. There were no signs of dermal irritation. One female showed no gain in bodyweight during the first week but expected gain in bodyweight during the second week. One other female showed expected gain in bodyweight during the first week but bodyweight loss during the second week. Remaining animals showed expected gains in bodyweight over the study period. No macroscopic abnormalities were observed at necropsy. The combined dermal LD50 of test item was considered to be higher than 2000 mg/kg bw in rats.

Conclusion

Under the test conditions, the acute dermal LD50 of test item is higher than 2000 mg/kg bw in rats therefore it is not classified according to CLP Regulation (EC) N° (1272 -2008).