2-benzyl-2-methyl-3-butenitrile

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-10-04 to 1991-02-14

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: according to OECD 402, GLP lack of data on the purity / quality of the sample tested

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-Benzyl-2-methyl-3-butennitrile

IUPAC Name:

2-Benzyl-2-methyl-3-butennitrile

Constituent 2

Reference substance name:

Citrowanil B, colourless spicy liquid

IUPAC Name:

Citrowanil B, colourless spicy liquid

Details on test material:

Citrowanil B

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Sprague-Dawley rats: Breeding Interfauna, Süddeutsche Versuchstierfarm, Tuttlingen
Veterinary preliminary examination: without morbid signs
Diet: Haltungsdiät alma 0801 H 1003, twice 8g daily
Water: free access by daily changing
Husbandry: the animals housed individually in Macrolon cages (area 800 cm², height 17 cm)
Temperature: 20 – 22 °C
Relative humidity: 45 – 70 %
Light-dark rhythm: 12 : 12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

One day before the application the dorsal area of the trunk was shaved in an area of 10 per cent of the body surface.
The liquid test substance was undiluted applied on the dorso-lumbar region of the rats.
The treated region was protected with gauze and an occlusive bandage for a period of 24 hours.

The animals were acclimatized to the test conditions for 5 days prior to the application.

Duration of exposure:

24 hours
At the end of the exposure period residual test substance was removed by gentling washing with water.

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Judgement during the study:
Mortality, behaviour, nutritional conditions, body weight, excrement, urine, hair, skin, nose, mouth, analregion, eye, respiration, nervous system, pathological findings

Statistics:

not nescessary

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD100

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 3

Sex:

male/female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

After the dermal application of 2000 mg Citrowanil B per kg body weight none of the 10 rats died during the observation period of 14 days.

Clinical signs:

other: During the exposure period of the test substance (24 hours) the food intake was reduced. In the remaining observation time the food was eaten up regularly and completly. Acute toxicological signs were found in one male rat with bloody urine only during th

Gross pathology:

The post-mortem findings after euthanasia (in CO2-atmosphere) did not show any macroscopic organ changes.

Any other information on results incl. tables

Body weights in g

testphase	day	male animals No					female animals No
		1	2	3	4	5*	1	2	3	4	5
acclimatization	-5	212	210	225	214	220	215	210	220	218	205
	-4	215	213	228	216	217	215	213	222	219	208
	-3	217	215	232	221	223	220	215	223	221	212
	-2	222	218	234	220	228	222	215	225	225	215
	-1	226	219	235	225	232	225	216	229	228	218
application	0	210	209	230	216	230	218	209	219	215	209
observation	1	212	201	225	210	232	212	207	210	212	200
	2	207	210	230	221	228	217	212	215	219	210
	3	205	205	229	219	230	213	209	214	215	209
	4	212	210	228	219	242	214	210	215	219	210
	5	217	219	231	221	246	215	209	217	218	210
	6	220	223	239	224	246	217	215	221	225	216
	7	224	226	248	226	248	222	218	225	227	219
	8	224	227	249	228	-	223	218	224	228	218
	9	-	-	-	-	254	-	-	-	-	-
	10	223	226	250	233	261	230	221	230	232	221
	11	220	230	258	242	-	240	218	240	231	230
	12	-	-	-	-	260	-	-	-	-	-
	13	228	232	250	238	262	244	223	238	230	236
	14	228	230	258	238	263	245	226	241	233	240

 

* Day of application one day later than the other animals. This animal showed the bloody sings in the urine during the exposure period.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

LD50 dermal, rat: > 2000 mg/kg b.w.
Not any skin irritation.

Executive summary:

The Acute Dermal Toxicity of Citrowanil B was determined in compliance with OECD 402 (1987).

Citrowanil B was applied in a dose of 2000 mg per kg weight dermal in each case to 5 male and 5 female Albino-Sprague Dawley rats.

Under the condition of this experiment Citrowanil B did not show any mortality.

Therefore, the experiment was finished as a limit test (LD50 dermal mor than 2000 mg per kg weight).

Acute toxicological signs were found in one male rat with bloody urine only during the exposure period of the first day. In other rats no toxicological signs were found.

The body weight of all rats had a normal physiological growth. Only in the first day after the application variations were observed.

The post-mortem findings after euthanasia did not show any macroscopic organ changes.