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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 19th, 2010 - June 2nd, 2010 (in-life phase)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP - Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
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):9-Octadecenoic Acid (9Z)-Decyl Ester
- Substance type:Clear colourless liquid
- Physical state: Liquid
- Analytical purity: 100% (acitve substance)
- Lot/batch No.: CA 00390004
- Expiration date of the lot/batch: 31 March 2010
- Storage condition of test material: At room temperature

Test animals

Species:
rat
Strain:
other: Wistar strain: Crl;WI (Han)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 10 Weeks old
- Weight at study initiation: Body weight variation did not exceed =/- 20% of the sex mean.
- Housing: Individually housed in labeled Makrolon cages (MIII type; height 18cm.) containing sterilised sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, UK).
- Diet :Free access to pelleted rodent diet (SM R/M-Z from SSNIFF Spezialdiäteb GmbH, Soest, Germany).
- Water : Free access to tap-water.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3°C (actual range: 19.6-21.2°c)
- Humidity (%): 40-70% (actual range: 39-62°c)
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/ 12 hour dark cycle


IN-LIFE DATES: From: 19/5/2010 To: 02/06/2010

Administration / exposure

Type of coverage:
occlusive
Details on dermal exposure:
TEST SITE
- Area of exposure: Back skin of the animal, approx. 25 cm2 for males and 18 cm2 for females.
- % coverage: 10% of the total body surface
- Type of wrap if used: The substance will be held in contact with the skin with a dressing, consisting of a surgical gauze patch, successively covered with aluminium foil and coben elastic bandage. A piece of Micropre tape will additionally be used for fixation of the bandages in female only.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin was cleaned of residual test substance using tap water.
- Time after start of exposure: 24 hours

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Bodyweights observed on day 1 (pre-administration), 8 and 15 and at death. Mortality/ viability was observed at least twice daily.
- Necropsy of survivors performed: yes, at the end of the observation period, all animals were sacrificed by oxygen/ carbon dioxide procedure and subjected to necropsy.
- Other examinations performed: clinical signs were observed at periodic intervals on the day of dosing (Day 1) and once daily thereafter, until day 15. The time of onset, degree and duration were recorded and the symptoms graded acrroding to fixed scales:
Maximum grade 4: grading slight (1) to very severe (4)
Maximum grade 3: grading slight (1) to severe (3)
Maximum grade 1: presence is scored (1).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred (Table 1).
Clinical signs:
Piloerection and/or chromodacryorrhoea were noted in all males on Day 1 and/or 2. No clinical signs of systemic toxicity were noted in females.
Scales, scabs, focal erythema were seen in the treated skin-area of all females and three males during the observation period.
Body weight:
The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity (Table 2).
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals (Table 3).

Any other information on results incl. tables

Table 1 Mortality Data:

Test Day

1

1

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

Hours After Treatment

0

2

4

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Males 2000 mg/kg

 

-

 

-

 

-

 

-

 

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

Females 2000 mg/kg

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

 

-

- = Sign not observed.

Table 2. Body weight (grams)

Sex/ dose level

Animal

Day 1

Day 8

Day 15

Male 2000 mg/kg

 

 

 

 

 

1

284

290

322

 

2

286

293

315

 

3

282

293

313

 

4

269

274

291

 

5

273

279

295

 

Mean

279

286

307

 

St.Dev

7

9

13

 

N

5

5

5

Females 2000 mg/kg

6

190

192

197

 

7

191

201

214

 

8

181

183

194

 

9

194

190

207

 

10

186

188

194

 

Mean

188

191

201

 

St.Dev

5

7

9

 

N

5

5

5

 

Table 3. Macroscopic Findings:

Animal Organ

Finding

Day of Death

Male 2000 mg/kg

 

 

1

No findings noted

Scheduled necropsy

Day 15 after treatent

2

No findings noted

Scheduled necropsy

3

No findings noted

Day 15 after treatent

4

No findings noted

Scheduled necropsy

5

No findings noted

Day 15 after treatent

Female 2000 mg/kg

No findings noted

Scheduled necropsy

Day 15 after treatent

6

No findings noted

Scheduled necropsy

Day 15 after treatent

7

No findings noted

Scheduled necropsy

Day 15 after treatent

8

No findings noted

Scheduled necropsy

Day 15 after treatent

9

No findings noted

Scheduled necropsy

Day 15 after treatent

10

No findings noted

Scheduled necropsy

Day 15 after treatent

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Conclusions:
Decyl octadec-9-enoate should not be classified for the acute dermal toxicity in accordance with Regulation (EC) n. 1272/2008.