Dinaphtho[1,2,3-cd:3',2',1'-lm]perylene-5,10-dione, (9,10-dihydro-9,10-dioxo-1-anthracenyl)amino derivs.

Endpoint summary

Description of key information

Skin irritation:

In the study considered to be key, the skin irritation potential of FAT 45082/D was evaluated according to OECD Guideline 404. In this study, FAT 45082/D with 54.6% purity was tested on rabbit’s skin. Under the experimental conditions employed FAT 45082/D induced erythema and edema reactions when applied to the clipped albino rabbit skin. However, the mean values of the recordings 24 to 72 hours after application are under the threshold of significance. Hence, FAT 45082/D can be classified as non-irritant according to the EEC directive No. 83/467/1983.

In a supporting study, FAT 45082/E with 28.7 % purity induced slight erythema reactions when applied to the clipped albino rabbit skin. The reactions were observed only one hour after removing the bandages.The mean values of the recordings 24 to 72 hours after application were scored to be zero. Hence, FAT 45082/E can be classified as non-irritant according to the EEC directive No. 83/467/1983.

Another supporting study with FAT 45082/B (purity: not known) was found to cause a minimal irritation when applied to intact and abraded rabbit skin. The calculated primary irritation index was 0.7. The mean reaction scores for intact skin were too low as compared to abraded skin.

Considering the results from the key and supporting studies it can be concluded that, FAT 45082 is non-irritating to rabbit’s skin.

 

Eye irritation:

The study considered to be key was performed to evaluate the eye irritation potential of FAT 45082/D. The test item FAT 45082/D with 54.6 % purity was tested on rabbit’s eye. Under the experimental conditions employed FAT 45082/D did not induce eye irritation when applied into the conjunctival sac of albino rabbits. According to the EEC directive No.83/467/1983 FAT 45082/D can, therefore, be classified as non-irritant.

In a supporting study, the test item FAT 45082/E with 28.7 % purity induced irritation of the cornea and conjunctiva when applied into the conjunctival sac of albino rabbits. The mean values of the readings 24 to 72 hours after application were below the threshold of significance. Hence, FAT 45082/E can be classified as non-irritant according to the EEC directive No.83/467/1983.

Under the conditions of another supporting experiment the test material FAT 45082/B (purity unknown) was found to cause a minimal irritation when applied to the rabbit eye mucosa. The primary irritation index was found to be: unrinsed eyes = 0.5; rinsed eyes = 0.4 . However, the reactions were reversible after 7 days of observation in both rinsed and unrinsed eyes. Hence substance is not expected to be eye irritant and can be concluded as non-irritant.

Considering the data from the key and supporting studies it can be concluded that FAT 45082 is non-irritating to rabbit’s eye

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:

19 February, 1985 to 22 March, 1985

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:

no

Specific details on test material used for the study:

Test substance: FAT 45082/D
Batch No.: EN 35713.42
Physical properties: powder; dispersible in water; pH: 8.5 (1 g/L water)
Validity: June 1989
Safety precautions: gloves and face masks
Test material received: February 11, 1985

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: approx. 12-14 weeks old
- Weight at study initiation: 2 to 3 kg
- Housing: The animals were housed individually in metal cages, identified with individually numbered ear tags
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day

IN LIFE PHASE- From: 19 February, 1985; To: 26 February, 1985

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent vehicle

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, and 72 hours

Number of animals:

3 male rabbits

Details on study design:

TEST SITE
- Area of exposure: at least 6 cm²
- Type of wrap if used: The patches were loosely covered with an aluminum foil (36 cm²)

SCORING SYSTEM:
The irritant / corrosive potency of FAT 45'082/D was classified according to the EEC commission directive No. 83/467/1983

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.78

Max. score:

4

Reversibility:

fully reversible within: 7 d

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.56

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

None

Other effects:

Body weight gain was normal during the experimental period.

Scoring tables

Erythema
Animal	1 hour		24 hours	48 hours	72 hours	7 days
69	2		2	2	1	0
70	2		1	1	0	0
71	1		0	0	0	0
Total	5		3	3	1
	1.67		1.00	1.00	0.33

Edema
Animal	1 hour		24 hours	48 hours	72 hours	7 days
69	1		2	1	0	0
70	1		1	1	0	0
71	1		0	0	0	0
Total	3		3	2	0
	1.00		1.00	0.67	0.00

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 45'082/D can be classified as non irritant according to the EEC directive No. 83/467/1983.

Executive summary:

The skin irritation potential of FAT 45082/D was evaluated in a study conducted according to OECD Guideline 404. 3 male rabbits were used for this purpose. Under the experimental conditions employed, FAT 45082/D induced erythema and edema reactions when applied to the clipped albino rabbit skin. The mean scores for erythema and edema were 0.78 and 0.56, respectively. Because the mean values of the scores at 24 to 72 hours after application were under the threshold of significance, FAT 45082/D can be classified as non-irritant according to the EEC directive No. 83/467/1983.

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:

05 March, 1985 to 27 March, 1985

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:

no

Specific details on test material used for the study:

Test substance: FAT 45082/D
Batch No.: EN 35713.42
Physical properties: powder; dispersible in water; pH: 8.5 (1 g/L water)
Validity: June 1989
Safety precautions: gloves and face masks
Test material received: February 11, 1985

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Maedorin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks old
- Weight at study initiation: 2 to 3 kg
- Housing: The animals were housed individually in metal cages, identified with individually numbered ear tags.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Photoperiod: 12 hours light cycle day

IN LIFE PHASE: From: 05 March, 1985; To: 08 March, 1985

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 g

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3 male rabbits

Details on study design:

0.1 g of FAT 45082/D was placed into the conjunctival sac of the right eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The left eye remained untreated and served as a control. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 45082/D.

SCORING SYSTEM: according to the OECD scoring system

TOOL USED TO ASSESS SCORE: A slit-lamp

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible within: 24 h

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritant / corrosive response data:

None

Other effects:

No effect on body weight gains was seen.

None

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 45082/D has no primary eye irritation potency in albino rabbits.

Executive summary:

The eye irritation potential of FAT 45082/D was evaluated in a study conducted according to OECD Guideline 405. 0.1 g of FAT 45082/D was placed into the conjunctival sac of the right eye of each of 3 male rabbits, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test material. The left eye remained untreated and served as a control. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 45082/D. Slight conjunctival redness and chemosis were reported at 1 hour observation, which was found to have reversed by 24 hours. Because no reactions were observed at 72 hours after instillation of FAT 45082/D, the test was ended after the 72 hours evauation. Based on these findings, it can be concluded, that FAT 45082/D has no primary eye irritation potency in albino rabbits.

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

FAT 45082 is found to be non-irritating to rabbit skin and eyes, hence it does not warrant classification according to the criteria of Regulation (EC) No. 1272/2008 (CLP).