Castor oil, sulfated, ammonium salt

Endpoint summary

Description of key information

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

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

in vivo eye irritation, test 1984, on analogue substance 1: H319 cat. 2

in vitro eye irritation on FLL sample 3 and 4: 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 analogue substance

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: 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)


SCORING SYSTEM: according to OECD guideline 404
Erithema, Edema

Irritation parameter:

erythema score

Basis:

animal: 1 and 4

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal: 2 and 5

Time point:

24/48/72 h

Score:

ca. 1.6

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal: 3 and 6

Time point:

24/48/72 h

Score:

ca. 2

Max. score:

2

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal: 1 and 5

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal: 2 and 4

Time point:

24/48/72 h

Score:

ca. 0.6

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal: 3 and 6

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

fully reversible

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

edema	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:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance was tested for skin irritation following method 29/7/1983 , 67/548 CEE. Under the experimental conditions the substance is not skin irritant.

Executive summary:

The substance was tested for skin irritation following method 29/7/1983 , 67/548 CEE. Six NZW rabbits were shaved and tested with occlusive method for 4 hours. Under the experimental conditions the substance is not skin irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

other: read across from analogue substance

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Good study, no GLP compliance

Qualifier:

according to guideline

Guideline:

other: 67/548/CEE

Deviations:

no

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: breeding center Padre Antonio
- Weight at study initiation:2 - 3 kg
- Housing: stainless steel cage 1472 Tecniplast with autowashing (10 sec. every hour)
- Diet: full pellet, ad libitum.
- Water: municipal water filtered with Seitz filter, ad libitum.
- Acclimation period: 7 days
- Healt check: 24 hours before treatment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±1
- Humidity (%): 55±15
- Air changes (per hr):8

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 ml/animale

Duration of treatment / exposure:

one injection

Observation period (in vivo):

1, 24, 48, 72h

Number of animals or in vitro replicates:

6

Details on study design:

SCORING SYSTEM: according to DAIZE test

TOOL USED TO ASSESS SCORE: fluorescein, and UV lamp (365 nm)

Irritation parameter:

cornea opacity score

Basis:

animal: 1,2,3 and 5

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

1

Reversibility:

not reversible

Irritation parameter:

cornea opacity score

Basis:

animal: 4 and 6

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

iris score

Basis:

animal: 1 and 5

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

1

Reversibility:

not reversible

Irritation parameter:

iris score

Basis:

animal: 2, 3, 4 and 6

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal: 1

Time point:

24/48/72 h

Score:

ca. 2.66

Max. score:

3

Reversibility:

not reversible

Irritation parameter:

conjunctivae score

Basis:

animal: 2 and 3

Time point:

24/48/72 h

Score:

ca. 2.33

Max. score:

3

Reversibility:

not reversible

Irritation parameter:

conjunctivae score

Basis:

animal: 4, 5 and 6

Time point:

24/48/72 h

Score:

ca. 2

Max. score:

2

Reversibility:

not reversible

Irritation parameter:

chemosis score

Basis:

animal: 1 and 6

Time point:

24/48/72 h

Score:

ca. 2.6

Max. score:

3

Reversibility:

not reversible

Irritation parameter:

chemosis score

Basis:

animal: 2, 4 and 5

Time point:

24/48/72 h

Score:

ca. 2

Max. score:

3

Reversibility:

not reversible

Irritation parameter:

chemosis score

Basis:

animal: 3

Time point:

24/48/72 h

Score:

ca. 1.6

Max. score:

2

Reversibility:

not reversible

tissue	observation period	rabbit						Mean
		1	2	3	4	5	6
Cornea	1h	0	0	0	0	0	0	0.00
	24h	1	1	1	0	1	0	0.66
	48h	1	1	1	0	1	0	0.66
	72h	1	1	1	0	1	0	0.66
	7days	1	1	1	0	1	0	0.66
Iris	1h	0	0	0	0	0	0	0.00
	24h	1	0	0	0	1	0	0.33
	48h	1	0	0	0	1	0	0.33
	72h	1	0	0	0	1	0	0.33
	7days	1	0	0	0	1	0	0.33
Conjunctiva	1h	2	2	2	2	2	2	2.00
	24h	3	3	3	2	2	2	2.50
	48h	3	2	2	2	2	2	2.16
	72h	2	2	2	2	2	2	2.00
	7days	1	1	1	1	1	1	1.00
chemosis	1h	2	2	2	2	2	2	2.00
	24h	3	2	2	3	3	3	2.83
	48h	3	2	2	2	2	3	2.33
	72h	2	2	1	1	1	2	1.50
	7days	1	0	1	1	0	1	0.66

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance was tested for eye irritation following 67/548/ECC method. Under the experimental conditions the conjunctivae score was > 2 and not reversible for the duration of the test for more thna 2/3 of animals.

Executive summary:

The substance was tested for eye irritation following 67/548/ECC method. Under the experimental conditions the conjunctivae score was > 2 and not reversible for the duration of the test for more thna 2/3 of animals.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), a substance is classified as Eye irritant Cat 2 if at least in 2 of 3 tested animals, a positive response of:

1)     corneal opacity ≥ 1 and/or

2)     2) iritis ≥ 1, and/or

3)      conjunctival redness ≥ 2 and/or

4)      conjunctival oedema (chemosis) ≥ 2

calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days. Based on the results of the means calculated over 24/48/72h reported in the key study the substance is classified as H319, Category 2.

According to the CLP Regulation (EC 1272/2008), a substance is considered as skin irritant cat2 if:

 1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or

 2)Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or

 3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.

Based on the results reported in the in vivo key study, the substance is not classified as skin irritant.