Fatty acids, C16-18, isotridecyl esters

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

May 19th, 2010 - June 2nd, 2010 (in-life phase)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP - Guideline study, tested with the source substance decyl oleate (CAS 3687-46-5). In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Decyl oleate

EC Number:

222-981-6

EC Name:

Decyl oleate

Cas Number:

3687-46-5

Molecular formula:

C28H54O2

IUPAC Name:

decyl octadec-9-enoate

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 or test system 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:

other: 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 obs

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

Remarks:

Migrated information Criteria used for interpretation of results: EU