2-Hexyl-2 ‘-hydroxy-5 ‘methyldecananilide

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 Feb - 18 Feb 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted 1992

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

adopted June 1996

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), November 2000, including most recent partial revisions

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): AF-654
- Physical state: white powder
- Lot/batch No.: #CE-201
- Expiration date of the lot/batch: 01 Jan 2005
- Storage condition of test material: at room temperature in the dark

Test animals

Species:

rat

Strain:

other: Wistar strain Crl:(WI) BR (outbred, SPF-Quality)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approximately 9 weeks
- Weight at study initiation: male (mean) 306 ± 14 g; female (mean) 216 ± 14 g
- Housing: individually in labelled Makrolon type III cages containing purified sawdust as bedding material
- Diet: standard pelleted laboratory animal diet (Altromin, code VRF1), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.4 - 22.9
- Humidity (%): 29 - 80
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

propylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: 25 cm² for males and 18 cm² for females
- % coverage: 10
- Type of wrap if used: surgical gauze patch, successively covered with aluminium foil and Coban elastic bandage, for females bandages were fixed using a piece of micropore tape

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned of residual test substance using water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg bw
- Constant volume or concentration used: yes
- Concentration (if solution): 200 mg/mL (w/w) (calculated from 10 mL/kg bw amount and 2000 mg/kg bw)

VEHICLE
- Amount(s) applied (volume or weight with unit): 10 mL/kg bw

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: checks were done twice daily for mortalities, clinical signs were recorded at periodic intervals on the day of dosing and once daily thereafter, body weights were determined before dosing (day 1) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality was observed during the study

Mortality:

No mortality occurred.

Clinical signs:

Flat/hunched posture and/or chromodacryorrhoea were noted among all animals between days 1 and 5.

Body weight:

Body weight gain was within the normal range during the study.

Gross pathology:

No toxicologically relevant abnormalities were found at macroscopic post mortem examination of the animals.

Other findings:

White staining of the treated skin area was noted among most animals between days 2 and 9. In addition, erythema (days 2 and/or 3) or scales (between days 3 and 12) of grade 1 were noted on the treated skin area of some females (table 2).

Any other information on results incl. tables

Table 1. Table for acute dermal toxicity

Dose [mg/kg bw]	Toxicological results*	Duration of clinical signs	Time of death	Mortality (%)
Males
2000	0/5/5	Day1 – Day5	---	0
Females
2000	0/5/5	Day1 – Day5	---	0
LD50 > 2000 mg/kg bw

 Day 1 refers to the day of test substance administration.                                                                                         

* first number = number of dead animals                                 

 second number = number of animals with clinical signs         

  third number = number of animals used                                                              

Table 2. Presence of skin effects

	Female rats					Male rats
Animal no.	1	2	3	4	5	1 - 5
White staining	Day2 – Day8	Day2	Day2 – Day8	Day2 – Day9	---	Day2 - Day8	Day2 - Day8	Day2 - Day8	Day2 - Day8	Day2 - Day8
Erythema (grade 1 - 4)	---	---	Day2 – Day3 (grade1)	---	Day2 (grade 1)	---	---	---	---	---
Scales (grade 1 - 3)	Day3 – Day12 (grade 1)	---	---	---	---	---	---	---	---	---

Day 1 refers to the day of test substance administration.     

---: sign not observed

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

DSD: not classified
CLP: not classified