Polyamide wax

Endpoint summary

Description of key information

In rabbit studies, the substance was considered to be not skin or eye 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:

From 2000-04-04 to 2000-07-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute 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 U.K.
- Age at study initiation: 11 to 13 weeks
- Weight at study initiation: 2.7 to 3.1 kg
- Housing: individually in stainless steel cages with perforated floors
- Diet (e.g. ad libitum): standard laboratory rabbit diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 20°C
- Humidity (%): 44 to 54%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): time switch of 12 hours of artificial light (0600-1800 hours GMT) in each 24 hours period

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: each animal served as its own control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g, undiluted

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 h after removal of the dressing and if relevant, daily until reversibility of reactions.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 25 mm*25mm
- Type of wrap if used: Elastoplast elastic adhesive dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm water (36°C) to remove residual test substance
- Time after start of exposure: 4 hours


SCORING SYSTEM: in accordance with the OECD guideline 404

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

See below table 1:
A transient well-defined erythema was observed in only one animal at 24 hours following dosing. No dermal irritation was observed in the two remaining animals throughout the observation period.

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Erythema	Edema
	Max. score: 2	Max. score: 0
24 h	0/2/0	0/0/0
48 h	0/0/0	0/0/0
72 h	0/0/0	0/0/0
Average 24h, 48h, 72h	0.0/0.67/0.0	0.0/0.0/0.0
Reversibility*)	C	-
Average time (unit) for reversion	Within 48 hours	-

C: Completely reversible

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not classified as skin irritating according to Regulation (EC) No. 1272/2008 and its subsequent amendments on classification, labeling and packaging (CLP) of substances and mixtures.

Executive summary:

The potential of the test item to induce skin irritation was assessed in 3 rabbits according to OECD Guideline 404 in compliance with Good Laboratory Practices.

A quantity of 0.5 g/flank was applied to a skin area under a semi-occlusive dressing for 4 hours. Skin reactions were observed 1, 24, 48, 72 hours after removal of the dressing. The mean values of the scores for erythema and oedema were calculated for each animal.

After a 4-hour exposure, a well defined erythema (grade 2) was noted in one animal only 24 hours after patch removal. No dermal irritation was observed in the two remaining animals throughout the observation period.

 The mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.67, 0.0 for erythema and 0.0, 0.0; 0.0 for oedema.

It was concluded that the test item required no classification for skin irritation according to regulation (EC) n°1272/2008.

 

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 2000-01-27 to 2000-07-25

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute 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 U.K.
- Age at study initiation: 11 to 13 weeks
- Weight at study initiation: 2.2 to 3.2 kg
- Housing: individually in metal cages with perforated floors
- Diet (e.g. ad libitum): standard laboratory rabbit diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 19.5 °C
- Humidity (%): 53 to 63%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): switch 12 hours of artificial light (6000-1800 hours GMT) in each 24 hours period

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (mean weight : 37mg) per animal used

Duration of treatment / exposure:

Not applicable: single application not followed by rinsing.

Observation period (in vivo):

1, 24, 48 and 72 h; since all animals showed no evidence of irritation after 72 hours, the evaluation of ocular reactions was stopped.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No


SCORING SYSTEM: Draize scale

- Conjunctival chemosis (lids and/or nictitating membranes):
0 no swelling
1 any swelling above normal (includes nictitating membranes)
2 obvious swelling with partial eversion of lids
3 swelling with lids about half-closed
4 swelling with lids more than half-closed

- Conjunctival redness (palpebral and bulbar conjunctivae, cornea and iris):
0 blood vessels normal
1 a number of blood vessels definitely hyperemic (injected)
2 diffuse, crimson colour, individual vessels not easily discernible
3 diffuse, beefy red

- Iris lesions
0 normal
1 markedly deepened rugae, congestion, swelling, moderate circum-corneal hyperemia,or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 no reaction to light, haemorrhage, gross destruction (any or all of these)

- Cornea intensity of opacity (direct examination and, if necessary, with an UV lamp)
0 no ulceration or opacity
1 scattered or diffuse areas of opacity (other than slight dulling or normal lustre), details of iris clearly visible
2 easily discernible translucent area, details of iris slightly obscured
3 nacreous areas, no details of iris visible, size of pupil barely discernible
4 opaque cornea, iris not discernible through the opacity

- Cornea area of opacity (direct examination and, if necessary, with an UV lamp)
1 one quarter (or less) but not zero
2 greater than one quarter but less than a half
3 greater than one half but less than three quarters
4 greater than three quarters up to whole area

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: at 48 hour observation period

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: at 48 hour observation period

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritant / corrosive response data:

No corneal damage or iridial inflammation was observed.
Conjunctival inflammation up to Grade 2 was notable in all three animals. Resolving in instances within 48 hours of dosing.

Other effects:

None

7.3.2.1 Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0	0/0/0	1/2/2	0/0/0
24 h	0/0/0	0/0/0	0/1/1	0/0/0
48 h	0/0/0	0/0/0	0/0/0	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0.0/0.0/0.0	0.0/0.0/0.0	0.0/0.3/0.3	0.0/0.0/0.0
Reversibility*)	-	-	C	-
Average time (unit) for reversion	-	-	48h	-

C: completely reversible

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not classified as eye irritating according to Regulation (EC) No. 1272/2008 and its subsequent amendments on classification, labeling and packaging (CLP) of substances and mixtures.

Executive summary:

The potential of the test item to induce eye irritation was assessed in rabbits according to OECD Guideline 405 in compliance with Good Laboratory Practice.

A volume of 0.1 mL of the test substance was placed into the conjunctival sac of one eye of three New Zealand White rabbits. The other eye remained untreated and was used for control purposes. Assessment of ocular damage/ irritation was made 1, 24, 48 and 72 hours following treatment according to the Draize scoring method. Since all animals showed no evidence of irritation after 72 hours, the evaluation of ocular reactions was stopped. The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal.

No corneal damage or iridial inflammation was observed. Conjunctival inflammation was observed in all animals with a maximum score of 2 but resolved within 48 hours after dosing. The mean individual scores were 0.0,0.3,0.3 for conjunctival redness and 0.0,0.0,0.0 for chemosis, corneal and iridial lesions.

It was concluded that the test item required no classification according to regulation (EC) n°1272/2008.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation / corrosion:

The potential of the test item to induce skin irritation was assessed in 3 rabbits according to OECD Guideline 404 in compliance with Good Laboratory Practices.

A quantity of 0.5 g/flank was applied to a skin area under a semi-occlusive dressing for 4 hours. Skin reactions were observed 1, 24, 48, 72 hours after removal of the dressing. The mean values of the scores for erythema and oedema were calculated for each animal.

After a 4-hour exposure, a well defined erythema (grade 2) was noted in one animal only 24 hours after patch removal. No dermal irritation was observed in the two remaining animals throughout the observation period.

 The mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.67, 0.0 for erythema and 0.0, 0.0; 0.0 for oedema.

Eye irritation / corrosion:

The potential of the test item to induce eye irritation was assessed in rabbits according to OECD Guideline 405 in compliance with Good Laboratory Practice.

A volume of 0.1 mL of the test substance was placed into the conjunctival sac of one eye of three New Zealand White rabbits. The other eye remained untreated and was used for control purposes. Assessment of ocular damage/ irritation was made 1, 24, 48 and 72 hours following treatment according to the Draize scoring method. Since all animals showed no evidence of irritation after 72 hours, the evaluation of ocular reactions was stopped.The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal.

No corneal damage or iridial inflammation was observed. Conjunctival inflammation was observed in all animals with a maximum score of 2 but resolved within 48 hours after dosing. The mean individual scores were 0.0,0.3,0.3 for conjunctival redness and 0.0,0.0,0.0 for chemosis, corneal and iridial lesions.

Justification for classification or non-classification

Based on the results from in vivo studies, the substance is not classified as a skin or eye irritant according to regulation EC No. 1272/2008 and its subsequent amendments on classification, labeling and packaging (CLP) of substances and mixtures.