PIGMENTADDITIV RL

Endpoint summary

Description of key information

No signs of skin or eye irritation were observed in reliable guideline studies. There is no study on respiratory irritation available. 

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 04 Apr 1989 to 07 Apr 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD TG 404), according to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(adopted 12 May 1981)

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

(Commission Directive 84/449/EEC, adopted 25 April 1984)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 1.8-2.2 kg
- Housing: individually
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage/Lippe), ad libitum, plus hay (about 15g/day)
- Water: deionised, chlorinated water, ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: polyethylene glycol 400

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 500 mg pasted with 0.65 ml polyethylene glycol 400 (Ch-B 2322, Riedel-de Haen)

Duration of treatment / exposure:

4 h

Observation period:

72 hours after end of exposure

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5x2.5 cm² cellulose patch of a surgical plaster (Baiersdorf)
- Type of wrap if used: semiocclusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm water
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD TG 404

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1, #2, #3

Time point:

other: 24, 48, and 72 hrs after end of exposure

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: slight erythema (score 1) in all animals one hour after end of exposure but not at later time points

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1, #2, #3

Time point:

other: 24, 48, and 72 hrs after end of exposure

Score:

0

Max. score:

4

Reversibility:

other: not applicable since no edema was visible at any time point

Irritant / corrosive response data:

Very slight erythema (score 1) occurred one hour after path removal. The skin of all animals was couloured purple at this time point.
Twenty four hours after end of exposure none of the animals showed any irritation reaction. The skin of one animal was coloured till 24 h after end of exposure. The skin of another animal was coloured till the end of the observation period.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item was not irritating to skin under the conditions of the test.

Executive summary:

The test item was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404 (adopted 12 May 1981) and GLP. Animals were treated with 500 mg of the test item (pasted with polyethylene glycol 400) for 4 h under semiocclusive conditions. Slight erythema (score 1) were observed in all three animals one hour after end of exposure, but not at later time points (mean score for the 24, 48, and 72 hrs reading: 0). No edema were observed at any time points. The skin of all animals was couloured purple one hour after end of exposure. Skin colouration retained in one animal till 24 hours after end of exposure and in another animal till 72 hours after end of exposure. The test item was not irritating to skin under the conditions of this test.

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:

experimental study

Adequacy of study:

key study

Study period:

From 11 Apr 1989 to 14 Apr 1989

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD TG 405), according to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(adopted 24 February 1987)

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

(Commission Directive 84/449/EEC, adopted 25 April 1984)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.3-2.9 kg
- Housing: individually
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage/Lippe), ad libitum, plus hay (about 15g/day)
- Water: deionised, chlorinated water, ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as internal control

Amount / concentration applied:

100 mg/eye

Duration of treatment / exposure:

24 h

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: Washing with physiological saline at approx. 37 °C 24 h after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution (24 and 72 h after administration) took place
- Time after start of exposure: 24 h

SCORING SYSTEM: according to guideline

TOOL USED TO ASSESS SCORE: 0.01 % solution of fluorescein sodium, under UV light

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Remarks:

all three animals

Time point:

other: 24, 48, 72 h

Score:

0.2

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

all three animals

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not relevant since no effects

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

all three animals

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not relevant since no effects

Irritation parameter:

iris score

Basis:

mean

Remarks:

all three animals

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not relevant since no effects

Irritant / corrosive response data:

Slight conjunctivae redness was observed in all animals one hour after application, but was no longer detectable in two animals at the 24 h reading. Only one animal revealed conjunctivae redness at the 24 h reading, but not at later time points (for details see table below). Chemosis (score 1 or 2) was observed in all animals one hour after application of the test item, but not at later time points. Iris and cornea were not affected.
A black discharge was observed in all animals at the 1 h reading. Diffuse crimson coloured conjunctivae was observed in one animal at 24 hours. No signs of irritation were apparent after 48 hours.

 

Time point after application	1 h			24 h			48 h			72 h
Animal no.	#1	#2	#3	#1	#2	#3	#1	#2	#3	#1	#2	#3
Cornea	0	0	0	0	0	0	0	0	0	0	0	0
Iris	0	0	0	0	0	0	0	0	0	0	0	0
Conjunctivae redness	1	1	1	2	0	0	0	0	0	0	0	0
Chemosis	1	2	2	0	0	0	0	0	0	0	0	0

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item was not irritating to the eyes of rabbits under the conditions of this test.

Executive summary:

The primary irritation potential of the test item was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand White rabbits according to OECD TG 405 (adopted 24 February 1987) and GLP. The treated eyes were rinsed with distilled water approximately 24 hours after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test article application.

Slight conjunctivae redness was observed in all animals one hour after application, but was no longer detectable in two animals at the 24 h reading. Only one animal revealed conjunctivae redness at the 24 h reading, but not at later time points. Chemosis (score 1 or 2) was observed in all animals one hour after application of the test item, but not at later time points. Iris and cornea were not affected. A black discharge was observed in all animals at the 1 h reading. Diffuse crimson coloured conjunctivae was observed in one animal at 24 hours. No effects were observed at the 48 h and 72 h reading. Due to the only sligth, reversible effects observed under the conditions of this test the test item was judged not to be irritating to the eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

No signs of skin irritation, neither oedema or erythema, were observed in rabbits in the reliable key study (RL 1) which was performed according to GLP (Hoechst, 1989).

Eye irritation:

Only slight and fully reversible effects were observed in the reliable key study (RL 1) on eye irritation in rabbits which was performed according to GLP (Hoechst, 1989). Mean scores for all three animals after the 24, 48 and 72 h reading were 0, 0, 0.3, and 0 for cornea, iris, conjunctivae redness and conjunctivae chemosis, respectively, i.e. no classification is necessary.

Respiratory irritation:

No study available

Justification for selection of skin irritation / corrosion endpoint:
Guideline study (OECD TG 404), according to GLP

Justification for selection of eye irritation endpoint:
Guideline study (OECD TG 404), according to GLP

Justification for classification or non-classification

As the submission substance was not irritating to the skin and caused only marginal and fully reversible effects to the eyes in two valid studies performed in accordance with OECD test guidelines and under GLP conditions no classification for eye, skin and respiratory irritation according to Regulation (EC) No 1272/2008 and Council Directive 67/548/EEC is required.