Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-, phosphosulfurized

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1970

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

substance was tested above the limit dose; missing data on animals

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-, phosphosulfurized

EC Number:

267-032-7

EC Name:

Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-, phosphosulfurized

Cas Number:

67762-73-6

IUPAC Name:

Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-, phosphosulfurized

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): EC 267-032-7
- Physical state: a viscous, pale yellow liquid with an unpleasant odor

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

No data present beyond the species, strain and that both sexes were used

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped abraded abdominal skin
- Type of wrap if used: binders of rubber dam, gauze and adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): cleansed with corn oil

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50, 200, 794, 3160 mg/kg bw

Duration of exposure:

24 hours

Doses:

50, 200, 794, 3160 mg/kg bw

No. of animals per sex per dose:

4 animals per dosage level. No data showing the number of sexes in each group

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals observed at 1, 4 and 24 hours and then daily. Observations were for mortality and toxic effects.
- Necropsy of survivors performed: yes

Statistics:

None

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 3 160 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No deaths observed at any dosage level

Mortality:

None

Clinical signs:

other: All animals showed slight or moderate erythema that never lasted beyond day 9. Desquamation noted at the 2 highest concentrations and edema and atonia observed in the highest. Severity and duration showed a dose response effect (see results table)

Gross pathology:

None observed

Any other information on results incl. tables

Signs of dermal irritation observed in male and female albino rabbits.

Observation interval (days)	50 mg/kg	200 mg/kg	794 mg/kg		3,160 mg/kg
	Erythema	Erythema	Erythema	Desquamation	Erythema	Edema	Atonia	Desquamation
1	+(4)	+(4)	+(3) ++(1)	-	+(2)++(2)	+(2)	-	-
2	-	+(1)	+(4)	-	+(2)++(2)	+(2)	-	-
3	-	-	+(4)	-	+(4)	-	+(1)	-
4	-	-	-	+(4)	+(3)	-	-	+(2)
5	-	-	-	+(3)	+(2)	-	-	+(2)
6	-	-	-	+(3)	+(1)	-	-	+(2)
7	-	-	-	+(3)	-	-	-	+(3)
8	-	-	-	+(1)	-	-	-	+(3)
9	-	-	-	-	-	-	-	+(1)

+ = slight

++ = moderate

+++ = severe

(x) = number of animals showing that effect

- = no toxicity observed

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 for the test substance dermal exposure to rabbits is assumed to be >3160 mg/kg bw as no mortality was observed ar any of the tested concentrations. The test substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.

Executive summary:

Following a protocol equivalent to OECD guideline 402, New Zealand white rabbits were exposed dermally to the test substance. Four rabbits were tested at each of the four concentrations. Some slight to moderate clinical effects were observed following a dose dependent pattern, but had all disappeared before the end of the observation period. No mortality was observed at any of the concentrations indicating the LD50 for dermal exposure to the registered substance is greater than 3160 mg/kg bw. No gross alterations were observed after necropsy of the animals. The registered substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.