AERO 5100 PROMOTER

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 Apr - 13 May 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted 24 February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

434-440-3

EC Name:

-

Cas Number:

86329-09-1

Molecular formula:

C8H15NSO

IUPAC Name:

O-(2-methylpropyl) prop-2-en-1-ylcarbamothioate

Test animals

Species:

rat

Strain:

other: Hsd:Sprague-Dawley(CD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, UK
- Age at study initiation: approx. 8 - 11 weeks
- Weight at study initiation: 212 - 312 g
- Housing: individually in metal cages (RS Biotech Sub-Dividable Rodent Cages - polished stainless steel, 20 cm high x 39 cm wide x 39 cm long)
- Diet: RM1(E) SQC expanded pellet (Special Diet Services), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 24
- Humidity (%): 34 - 58
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 50 mm x 50 mm clipped skin of the dorso-lumbar region
- % coverage: approx. 10%
- Type of wrap if used: The treated skin was covered with porous gauze held in place with non irritating dressing and further covered by a waterproof dressing encircled firmly around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test substance was removed with warm water (30 to 40 °C).
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2.021 mL/kg bw

Duration of exposure:

24 h

Doses:

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 soon after dosing at frequent intervals for the remainder of Day 1. On subsequent days animals were observed once in the morning and again at the end of the experimental day (with exception of Day 15 - morning only). Individual body weights were determined on Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: The nature and severity of the clinical signs and time were recorded at each observation.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Clinical signs of reaction to treatment were confined to one animal and characterised by lethargy, partially closed eyelids and pallid extremities (notable between 4 and 6 h after dosing only). There were no signs of reaction to treatment in any of the ni

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

Well-defined dermal irritation was observed on four males and four females resolving completely by Day 8. The signs were accompanied in the occasional animal by localised reactions characterised by desquamation of the stratum corneum, necrosis and a patchy (dry area of skin) response at the edge of the treatment site in one further female. There were no other signs of reaction to treatment and recovery was complete in all instances by Day 9.

Any other information on results incl. tables

Table 1. Dermal reactions observed following 24 h exposure with undiluted test substance.

Dose (mg/kg bw)	Sex	Animal no.	E = Erythema O = Oedema	Days after dosing
				2	3	4	5	6	7	8	9 to 15
2000	Male	1	E	1	1	0	0	0	0	0	0
			O	1	0	0	0	0	0	0	0
		2	E	0	0^A	0^A	0	0	0	0	0
			O	0	0	0	0	0	0	0	0
		3	E	1	1	0	0	0	0	0	0
			O	0	0	0	0	0	0	0	0
		4	E	2	1	0	0	0	0	0	0
			O	1	1	0	0	0	0	0	0
		5	E	2	1	1	0	0	0	0	0
			O	1	1	0	0	0	0	0	0
	Female	1	E	2	2^B	2^A,B	2^A	2^A	1^A	0^A	0
			O	2	3	3	2	1	0	0	0
		2	E	2	2^A	2^A	2^A	2^A	1^A	0^A	0
			O	1	1	1	1	1	0	0	0
		3	E	2	1^A	1^A	1^A	1^A	0^A	0	0
			O	1	1	1	1	1	0	0	0
		4	E	0	0	0	0	0	0	0	0
			O	0	0	0	0	0	0	0	0
		5	E	2^C	1^C	1^C	0	0	0	0	0
			O	1	1	0	0	0	0	0	0

A: desquamation of the stratum corneum (characterized by dryness and sloughing and/or scaling)

B: necrosis (localized)

C: patchy response (dry area of skin) at edge of dose site

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

In this acute dermal toxicity study a LD50 value > 2000 mg/kg bw in male and female rats was found.