AERO 5100 PROMOTER

Endpoint summary

Description of key information

Skin irritation/corrosion (OECD 404): not irritating

Eye irritation (OECD 405): 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:

experimental study

Adequacy of study:

key study

Study period:

28 Apr - 11 May 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 17 July 1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, UK
- Age at study initiation: approx. 11 - 13 weeks
- Weight at study initiation: 2.6 - 3.0 kg
- Housing: individually in stainless steel cages with perforated floors, hay was available on a regular basis
- Diet: STANRAB (P) SQC pellet ( Special Diet Services), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 26 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5 - 22.5
- Humidity (%): 41 - 64
- Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

14 days
Reading time points: 1, 24, 48 and 72 h and subsequently daily up to Day 14

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: 100 x 100 mm on the dorso-lumbar region
- Type of wrap: The test substance was applied to the skin under a 25 mm x 25 mm gauze pad. Each treatment site was covered with "Elastoplast" elastic adhesive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: The treatment site was washed with warm water (39 °C) to remove any residual test substance.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 13 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 13 days

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Well-defined erythema with very slight to slight oedema was seen in all animals. In addition, desquamation of the stratum corneum (characterised by dryness and sloughing) developed in 2 animals. Reactions gradually ameliorated and had resolved completely in 2 animals by either Day 7 or 13. Very slight erythema and desquamation was still evident in the remaining animal at study termination on Day 14.

Other effects:

There were no signs of toxicity or ill health in any animal during the observation period.

Table 1. Results of the skin irritation study following 4 h exposure with undiluted test substance.

Observation time (Day)	Rabbit no.
	1		2		3
	Erythema	Edema	Erythema	Edema	Erythema	Edema
1 h	2	1	0	0	0	0
2	2	1	2	2	2	2
3	2	1	2	1	2	1
4	2	1	2	2	1	1
5	2	1	2	2	1	0
6	2^D	1	2^D	2	1	0
7	2^D	1	2^D	2	0	0
8	2^D	1	2^D	1	-	-
9	2^D	1	2^D	2	-	-
10	2	1	2^D	2	-	-
11	1	1	2^D	2	-	-
12	1	1	2^D	2	-	-
13	0	0	2^D	1	-	-
14	-	-	1^D	0	-	-

D: desquamation of the stratum corneum (characterized by dryness and sloughing of the skin)

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

Under the conditions of the Acute Dermal Irritation/Corrosion Test in rabbits the test substance does not possess any skin irritating potential.

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:

6 - 11 May 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 24 Feb 1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, UK
- Age at study initiation: approx. 11 - 12 weeks
- Weight at study initiation: 2.5 - 2.9 kg
- Housing: individually in metal cages with perforated floors, hay was available on a regular basis
- Diet: STANRAB (P) SQC pellet (Special Diet Services), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 27 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 - 23
- Humidity (%): 46 - 65
- Photoperiod (hrs dark / hrs light): 12 / 12

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

72 hours
Reading time points: 1, 24, 48 and 72 hours after treatment

Number of animals or in vitro replicates:

3 females

Details on study design:

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: handheld light

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

animal: #1 and #2

Time point:

24/48/72 h

Score:

0.7

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Irritation parameter:

chemosis score

Basis:

animal: #1 and #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritant / corrosive response data:

No corneal damage or iridial inflammation was observed. A diffuse, beefy red colouration of the conjuctivae and swelling with partial eversion of the eyelids was seen in two animals. Transient hyperaemia of blood vessels with slight swelling was observed in the remaining animal. The reactions had resolved completely within 3 days after instillation.

Other effects:

There were no signs of toxicity or ill health in any animal during the observation period.

Table 1. Results of the eye irritation study

Animal	Time (h)	Conjunctivae		Cornea	Iris
		Redness	Chemosis
1	1	1	1	0	0
	24	1	0	0	0
	48	1	0	0	0
	72	0	0	0	0
	Average 24+48+72	0.7	0	0	0
2	1	3	2	0	0
	24	1	0	0	0
	48	1	0	0	0
	72	0	0	0	0
	Average 24+48+72	0.7	0	0	0
3	1	3	2	0	0
	24	2	1	0	0
	48	1	0	0	0
	72	0	0	0	0
	Average 24+48+72	1	0.3	0	0

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

Under the conditions of this eye irritation study in rabbits the test substance was not irritating to the eye.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin

The skin irritation potential of the test substance was determined by an in vivo skin irritation test (Parcell, 1998) in albino rabbits according to OECD Guideline 404 and in compliance with GLP. 0.5 mL of the undiluted test substance was applied to the clipped skin of three rabbits under semiocclusive conditions for 4 hours. After the exposure period the patch was removed and the administration area was rinsed with warm water. Scores were taken 1 h after patch removal and once daily thereafter for 14 days using the Draize scoring system. Well-defined erythema (score 2) with very slight to slight oedema (score 1-2) was seen in all animals within 24 hours. In addition, desquamation of the stratum corneum (characterised by dryness and sloughing) developed in 2 animals by Day 6. Reactions gradually ameliorated and had resolved completely in 2 animals by either Day 7 or 13. Very slight erythema (score 1) and desquamation was still evident in the remaining animal at study termination on Day 14. Based on the results, the undiluted test substance was not irritating to the skin under the test conditions.

 

Eye

The eye irritation potential of the test substance was investigated in three albino rabbits according to OECD Guideline 405 (Parcell, 1998) and in compliance with GLP. 0.1 mL of the undiluted test substance was placed in one eye of each animal. The other eye remained untreated and served as control. The eyes were examined and scored according to the Draize scoring system 1, 24, 48 and 72 hours after application. No corneal damage or iridial inflammation was observed. Redness of conjunctivae (grade 3) and chemosis (grade 2) with partial eversion of the eyelids was seen in two animals 1 hour after instillation. Conjunctivae redness (grade 1) with slight chemosis (grade 1) was observed in the remaining animal. The reactions had resolved completely within 3 days after instillation. Based on the results of this study, the test substance was not irritating to the eyes under the conditions of the test.

 

In a supporting study, the eye irritation potential of the test substance was investigated in nine albino rabbits similar to OECD Guideline 405 (Mayhew, 1981) and in compliance with GLP. 0.1 mL of the undiluted test substance was placed in one eye of each animal. The other eye remained untreated and served as control. In three animals eyes were rinsed with lukewarm water 30 seconds after instillation, in the remaining 6 animals the eyes were not rinsed. The eyes were examined and scored according to the Draize scoring system 24, 48 and 72 hours after application and at Day 4 and 7. No corneal damage or iridial inflammation was observed. Slight redness of conjunctivae (grade 1) and chemosis (grade 1) was observed at 24 hours after instillation in 5/6 animals with non-rinsed eyes and in all animals with rinsed eyes. The reactions had resolved completely within 48 hours. Based on the results of this study, the test substance was not irritating to the eyes under the conditions of the test.

Justification for classification or non-classification

The available data on skin and eye irritation of the test substance do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and are therefore conclusive but not sufficient for classification.