Synthetic resin, a reaction product of 4,4'-bis(N-maleimido)diphenylmethane with 3-aminobenzoic acid hydrazide

Endpoint summary

Description of key information

Skin irritation:

- study according to OECD guideline 404, GLP, New Zealand rabbits were exposed to 0.5 g MDAB for 4 h, not irritating, read-across

- study according to OECD guideline 404, GLP, New Zealand rabbits were exposed to 0.5 g ABH for 4 h, not irritating , read-across

Eye irritation:

- study according to OECD guideline 405, GLP, 0.1 g of MDAB were instilled into the conjunctival sac of the left eye of three New Zealand rabbits, theanimals were observed for 7 days, reading intervals: 1, 24, 48 and 72 h after application, not irritating, read-across

- study according to OECD guideline 405, GLP, 0.1 g of ABH were instilled into the conjunctival sac of the left eye of three New Zealand rabbits, theanimals were observed for 21 days, reading intervals: 1, 24, 48 and 72 h after application, not irritating, read-across

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1989-10-27 to 1989-12-28

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:

February, 1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

March, 1984

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: males 14 weeks, female 15 weeks
- Weight at study initiation: males 2.4 - 2.5 kg, female 2.6 kg
- Fasting period before study: overnight
- Housing: female individually, males 2 animals/cage; stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, D-7830 Emmendingen)
- Diet: ad libitum, pelleted standard Kliba 341, Batch 48/89 rabbit maintenance diet ("Kliba", Klingenmuehle AG, CH-4303 Kaiseraugst)
- Water: ad libitum, community tap water from Itingen
- Acclimation period: 4 days under test conditions after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Remarks:

The test article was applied moistened with bi-distilled water

Controls:

not required

Amount / concentration applied:

0.5 g/animal. The test article was applied moistened with bi-distilled water.

Duration of treatment / exposure:

4 hours

Observation period:

72 h with the reading points: 1, 24, 48 and 72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). On test day 1, 0.5 g of the test article was applied to approx. 6 cm² of the intact skin of the shaved area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze.
- Type of wrap if used: Covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water.

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48 and 72 h

SCORING SYSTEM: Draize scoring system
- Method of calculation: according to EEC Council Directive 83/467/EEC, July 1983, Brussels, Belgium

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #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, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The test item showed a primary irritation score of 0.00, when applied to intact rabbit skin. Local signs (mean 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident an the skin.

Other effects:

Coloration: In the area of application no staining of the treated skin by pigment or coloring of the test article was observed.
Body weights: The body weight gain of all rabbits was similar.
Clinical symptoms / Mortality: No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.
Necropsy: No necropsy was performed. All animals were killed and discarded.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this experiment, The test substance was found to cause a primary irritation score of 0.00, when applied to intact rabbit skin. There was no sign of irritation, thus, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) with respect to skin irritation.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1989-10-27 to 1989-12-28

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted February 24, 1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

not reported

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: females: 15 weeks; male: 14 weeks
- Weight at study initiation: females: 3.0 kg; male: 2.5 kg
- Housing: Individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, D-Emmendingen)
- Diet (e.g. ad libitum): ad libitum, pelleted standard Kliba 341, Batch 48/89 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4304 Kaiseraugst)
- Water (e.g. ad libitum): ad libitum, Community tap water from Itingen
- Acclimation period: four days under test condictions after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Remarks:

moistened with bi-distilled water

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

4h

Observation period:

72 h, reading intervals: 1, 24, 48 and 72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: patch of surgical gauze covered with a semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): four hours after the application the skin was flushed with lukewarm tap water

OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
1, 24, 48 and 72 h after the removal of the dressing

SCORING SYSTEM:
- Method of calculation: The results were scored according to OECD guideline 404 (Draize et al.)

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

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: 4	Max. score: 2
24 h	2/1/1	0/0/0
48 h	1/0/0	0/0/0
72 h	0/0/0	0/0/0
Average 24h, 48h, 72h	1/0.33/0.33	0/0/0
Reversibility*)	c.	c.
Average time (h) for reversion	48h	No effect occurred

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Interpretation of results:

GHS criteria not met

Conclusions:

In the present study conducted according to OECD guideline 404, GLP-compliant, three New Zealand White rabbits were dermally exposed under semi-occlusive conditions to 0.5 g test substance for 4h. After the 4h treatment the remaining substance was removed and the appearance of erythema and edema was scored. Mean erythema scoring for 24, 48 and 72h was 0.33/0.33/0, mean edema scoring for 24, 48 and 72h was 0/0/0. Therefore, the substance does not meet the GHS criteria for classification and is not classified and labeled according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-11-02 to 1989-12-19

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 February 24, 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
- Age at study initiation: males 14 weeks, female 15 weeks
- Weight at study initiation: males 2.5-2.6 kg, female 2.4 kg
- Housing: individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing WE. Ehret GmbH, Versuchstiertechnik, D-7830 Emmendingen)
- Diet: ad libitum, pelleted Kliba 341, Batch 48/89 and 49/89 rabbit maintenance diet ("Kliba", Kingenmuehle AG, CH-4303 Kaiseraugst)
- Water: ad libitum, community tap water from Itingen
- Acclimation period: 4 days under laboratory conditions after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 g of the test substance was instilled into the conjunctival sac of the left eye
- Concentration: undiluted

Duration of treatment / exposure:

7 days, single exposure, no washing

Observation period (in vivo):

7 days, Reading points: 1, 24, 48 and 72 hours

Number of animals or in vitro replicates:

3

Details on study design:

The test article (0.1 g per animal) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The right eye remained untreated and served as the reference control.

REMOVAL OF TEST SUBSTANCE
- Washing : No

SCORING SYSTEM: According to OECD guideline 405 (Draize et al.)

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 7 days

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

Corrosion: Corneal opacity was observed in one animal (no.71, female) from 1 to 72 hours after treatment. No opacity was observed in any other animal.

Other effects:

Clinical symptoms / Mortality: No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.
Coloration: No staining of the cornea and conjunctivae of the treated eyes by pigment or coloring of the test article was observed.
Body weights: The body weight gain of all rabbits was similar.
Necropsy: No necropsy was performed. All animals were killed and discarded.

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	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
24 h	0/0/1	0/0/1	2/2/2	1/1/2
48 h	0/0/1	0/0/0	2/2/2	0/0/1
72 h	0/0/1	0/0/0	1/1/1	0/0/0
Average 24h, 48h, 72h	0/0/1	0/0/0.33	1.67/1.67/1.67	0.33/0.33/1
Reversibility*)	c.	c.	c.	c.
Average time for reversion	72h	72h	7days	72h

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

 

Interpretation of results:

GHS criteria not met

Conclusions:

In the present study conducted according to OECD guideline 405 (adopted February 24, 1987) 0.5 g Compimide MDAB were instilled into the conjuctival sac of three New Zealand White rabbits (two male and one female animal). The treated eyes were not rinsed and the effects of the test item were recorded at 1h, 24h, 48h and 72h after application. After another 21 days observation period the animals were sacrificed and discarded. In all three animals a slight conjunctival redness was detected at the 72h reading (score 1) but the redness was fully reversible within 7 days, thus, the test item does not need to be classified according to Regulation (EC) No 1272/2008 (CLP) and the globally harmonized system of classification and labelling of chemicals (GHS).

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1989-11-02 to 1989-12-20

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted February 24, 1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

not reported

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Remarks:

SPF-quality

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: females: 15 weeks; male: 14 weeks
- Weight at study initiation: females: 2.5-2.7 kg; male: 2.6 kg
- Housing:Individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, D-Emmendingen)
- Diet (e.g. ad libitum): ad libitum, pelleted standard Kliba 341, Batch 48/89 rabbit maintenance diet ("Kliba", Klingentalmuehle AG, CH-4304 Kaiseraugst)
- Water (e.g. ad libitum): ad libitum, Community tap water from Itingen
- Acclimation period: four days under test condictions after veterinary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of the substance were instilled into the conjunctival sac of the left eye.

Duration of treatment / exposure:

21 days, single exposure, no washing

Observation period (in vivo):

The animals were observed for 21 days with the reading time points: 1, 24, 48 and 72 hours after exposure

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM: according to OECD guideline 405

TOOL USED TO ASSESS SCORE: Eye examinations were made with a slit-lamp 30 SL/M (C. ZeissAG, Zuerich, Switzerland)

100 mg of the test article (undiluted) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The eyes were not rinsed.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible

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	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
24 h	0/0/0	0/0/0	1/1/1	0/0/1
48 h	0/0/0	0/0/0	1/1/1	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	0.67/0.67/0.67	0/0/0.33
Reversibility*)	c.	c.	c.	c.
Average time (h) for reversion	48	48	48	48

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Interpretation of results:

GHS criteria not met

Conclusions:

In the present study conjducted according to OECD guideline 405 (adopted February 24, 1987), 0.1 g m-aminobenzohydrazide (ABH) were instilled into the conjunctival sac of the left eye of three New Zealand rabbits. The eyes were not rinsed and the effects of the substance on the rabbit eye were assessed at 1, 24 48 and 72h after application of the substance. The opacity score was < 1 (0/0/0), the iris score was < 1 (0/0/0), the conjuntivae score was < 2 (0.67/0.67/0.67) and the chemosis score was < 2 (0/0/0.33). Therefore, ABH is considered to be not irritating to the eye and is not classified according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemcials (GHS).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

There are no experimental data on the target substance Compimide 183 available. However, irritation/corrosion studies are available for the source substance MDAB and ABH. A detailed justification for read-across is attached to IUCLID section 13.

Irritation/Corrosion

Skin irritation/corrosion

No data about skin irritation/corrosion for the target substance Compimide 183 are available. However, there are reliable data for the structurally similar source substances MDAB and ABH.

In study conducted according to OECD guideline 404, GLP, 3 New Zealand rabbits were dermally exposed to 0.5 g MDAB for 4 h under semi-occlusive conditions. The animals were observed for 72 h after the 4 h exposure time. The reading-intervals were: 1 h, 24 h, 48 h and 72 h. There were no signs of irritation at any timepoint of the observation period, thus MDAB was not classified as skin irritant according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).

In study conducted according to OECD guideline 404, GLP, 3 New Zealand rabbits were dermally exposed to 0.5 g ABH for 4 h under semi-occlusive conditions. The animals were observed for 72 h after the 4 h exposure time. The reading-intervals were: 1 h, 24 h, 48 h and 72 h. Slight irritation was observed 24 h after application which was fully reversible within the 72 h of the observation period, thus ABH was not classified as skin irritant according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).

Eye irritation/corrosion

In study conducted according to OECD guideline 405, GLP, 0.1 g of MDAB were instilled into the conjunctival sac of the left eye of 3 New Zealand rabbits. The animals were observed for 7 days after exposure with the following reading-intervals: 1 h, 24 h, 48 h and 72 h. Slight corneal opacity, irritation of the iris and chemosis and a moderate conjunctival irritation was detected in one animal at least one reading timepoint of the observation period but these effects were fully reversible within 7 days, thus MDAB was not classified as skin irritant according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).

In study conducted according to OECD guideline 405, GLP, 0.1 g of ABH were instilled into the conjunctival sac of the left eye of 3 New Zealand rabbits. The animals were observed for 7 days after exposure with the following reading-intervals: 1 h, 24 h, 48 h and 72 h. Slight conjunctival irritation was detected in all animals at least two reading timepoints and one animal showed chemosis at the 24 h reading timepoint of the observation period. These effects were fully reversible within 48 h, thus ABH was not classified as skin irritant according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS).

Justification for classification or non-classification

Based on the results of the reported skin and eye irritation studies neither MDAB no ABH are irritating to the skin or the eyes, thus, also Compimide 183 (the reaction product of both compounds) is considered to be not irritating to the skin and the eyes and does not need to be classified according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemcials (GHS).