Ethyl 3,5-dichloro-4-hexadecyloxycarbonyloxybenzoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

30 Nov-14 Dec 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions. The test substance (a solid) was applied under occlusive conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted in February 1987

Deviations:

yes

Remarks:

exposure under occlusive conditions

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

404-740-9

EC Name:

-

Cas Number:

115895-09-5

Molecular formula:

C26H40Cl2O5

IUPAC Name:

ethyl 3,5-dichloro-4-{[(hexadecyloxy)carbonyl]oxy}benzoate

Details on test material:

- Name of test material (as cited in study report): AF-366
- Physical state: white powder
- Analytical purity: no data

Test animals

Species:

rat

Strain:

other: Wistar outbred (Bor:WISW)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeding Centre for Laboratory Animals, F. Winkelmann GmbH, Borchen, Germany
- Age at study initiation: approximately 19 weeks
- Weight at study initiation: 310-360 g (males), 190-230 g (females)
- Housing: before dosing, the rats were housed in groups of five per sex, in stainless steel cages with a wire-screen bottom and front. After dosing, the rats were housed individually in stainless steel cages with a wire-screen bottom and front.
- Diet: CIVO cereal-based, open-formula diet for rats, ad libitum
- Water: tap water, ad libitum
- Acclimation period: approximately 14 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24
- Humidity (%): 40-60
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 30 Nov 1988 To: 14 Dec 1988

Administration / exposure

Type of coverage:

occlusive

Vehicle:

maize oil

Details on dermal exposure:

TEST SITE
- Area of exposure: the dorsal and ventral clipped area of the trunk of the animals
- Type of wrap if used: the test material was held in contact with the skin with a plastic film, which was secured by an elastic adhesive bandage (Tensoplast) around the trunk of the rat

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the residual test material was cleaned from the treated area with water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 8 mL/kg bw
- For solids, paste formed: no, a suspension was prepared

VEHICLE
- Amount(s) applied (volume or weight with unit): 8 mL/kg bw
- Concentration (if solution): 75%

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations of clinical signs were made several times on Day 0 (post-administration) until 4 hours after dosing and daily thereafter; weighing was performed on Day 0 (pre-administration), 3, 7 and 14; skin irritation effects were assessed on Day 1, 3 and 7
- Necropsy of survivors performed: yes, all gross pathological changes were recorded
- Other examinations performed: clinical signs, mortality, skin irritation

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no mortality during the 14-day study period (see Table 1).

Clinical signs:

other: 5/5 males and 5/5 females were moderately sluggish from 1 up to 4 hours after administration of the test substance. Piloerection was observed at the 24-hour reading time point only, in 5/5 males and 5/5 females (see Table 1).

Gross pathology:

No treatment-related effects were observed during the gross pathological examination.

Other findings:

- Other observations: there were no skin irritation effects following exposure to the test substance

Any other information on results incl. tables

Table 1: Mortality and clinical signs

Dose [mg/kg bw]	Toxicological results*	Duration of clinical signs	Time of death	Mortality (%)
Males
2000	0/5/5	1-24 h	-	0
Females
2000	0/5/5	1-24 h	-	0
Overall LD50 > 2000 mg/kg bw

* first number = number of dead animals                                 

 second number = number of animals with systemic clinical signs         

 third number = number of animals used                               

 

Table 2: Individual and mean body weight changes

Body weight (g)
	Day 0	Day 3	Day 7	Day 14
Males
1	344	333	346	354
2	310	304	320	328
3	350	342	363	375
4	358	352	354	354
5	360	360	361	372
Mean body weight, males (g)	344	338	349	357
6	228	223	223	220
7	190	180	190	180
8	230	221	204	221
9	203	200	208	201
10	196	193	193	196
Mean body weight, females (g)	209	203	204	204

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified