Rape oil, sulfated, ammonium salt

Endpoint summary

Description of key information

in vivo skin irritation, test 1984, NZW rabbit on the substance 1: not skin irritant

in vitro skin irritation on FLL sample 3, sample 4 and sample 6, OECD 431: not skin irritant

in vitro eye irritation on FLL sample 3, 4 and 6: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: read across from an old study, no guideline followed.

Qualifier:

equivalent or similar to guideline

Guideline:

other: 67/548 CEE

Deviations:

no

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Housing:iron stainless steel cage model 1472 "tecniplast"
- Diet : pellet, ad libitum
- Water : municipal filtered water, ad libitum
- Acclimation period:7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 ± 1°C
- Humidity (%): 55 ± 15%
- Air changes (per hr):8 per hour
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g

Duration of treatment / exposure:

one application/ 4 hours

Observation period:

24, 48, 72 hours , 5, and 7 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: ~ 10 cm^2
- % coverage:
- Type of wrap if used:multiple foil surgical gauze (2.5 X 2.5 cm). The gauze is fixed by ipoallergenic adhesive bandage (Blenderm BM). The entire animal's trunk is protected by elastic bandage (Acrylastic Beyersdorf)

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

SCORING SYSTEM: according to OECD guideline 404
Erithema, Edema

Irritation parameter:

erythema score

Basis:

mean

Time point:

7 d

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

mean

Time point:

7 d

Score:

ca. 0

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal:

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Remarks:

at the time of testing no readings at 24, 48 and 72h were required by the guidelines

Irritation parameter:

edema score

Basis:

animal:

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Remarks:

at the time of testing no readings at 24, 48 and 72h were required by the guidelines

erithema	check	1	2	3	4	5	6	mean
	24h	1	2	2	1	2	2	1.66
	48h	1	2	2	1	2	2	1.66
	72h	1	1	2	1	1	2	1.33
	5d	0	1	1	1	1	1	0.83
	7d	0	0	0	0	0	0	0

erithema	check	1	2	3	4	5	6	mean
	24h	1	1	0	1	1	0	0.66
	48h	1	1	0	1	1	0	0.66
	72h	1	0	0	0	1	0	0.33
	5d	0	0	0	0	0	0	0
	7d	0	0	0	0	0	0	0

Interpretation of results:

other: not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Based on results the product Castor oil don't presents any signs of irritation

Executive summary:

Castor oil is tested by Decree 29/7/1983 67/548/CEE .Test item is applied on skin of six Newzeland albino rabbit. Based on results the product Castor oil don't present any signs of irritation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The substance is not considered irritant or corrosive to skin and eye according to the criteria set out in the Regulation EC 1272/2008 (CLP).