Benzenamine, N-phenyl-, reaction products with 2,4,4-trimethylpentene

Endpoint summary

Description of key information

Slight reversible effects on rabbit eyes and skin were observed in reliable animal studies.

The effects on skin do not warrant classification and labelling in the EU. Applying UN GHS criteria, criteria for category 3 (skin) are fulfilled.

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:

14.1.-24.1.1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non GLP (performed 1988), OECD conform, 3 animals used, observation period 7 days even if effects still visible, no autopsy

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:

- Physical state: liquid
- Lot/batch No.: EN 65360.22.368
- Expiration date of the lot/batch: 12/1983
- Storage condition of test material: room temperature

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: 12 - 14 weeks
- Weight at study initiation: 2 - 3 kgs
- Housing: Animals were housed individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland) ad libitum.
- Water: ad libitum
- Acclimation period: 4 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

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

Duration of treatment / exposure:

4 h

Observation period:

7 d

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: back
- coverage: at least 6 sq. cm
- Type of wrap if used: non-irritating adhesive tape

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1,24,48,72 h and 7 d

Score:

1 - 2

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 1, 24, 48, 72 h and 7 d

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 1, 24, 48, 72 h and 7 d

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 1, 24, 48, 72 h and 7 d

Score:

1 - 2

Max. score:

4

Reversibility:

not fully reversible within: 7 days

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 1, 24, 48, 72 h and 7 d

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 1, 24, 48, 72 h and 7 d

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Conclusions:

EC 270-128-1 was found to be slightly irritant to skin, scores are below the threshold for classification and labelling as an irritant in the European Union which has not implemented GHS category 3 for skin irritation.

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:

14/01/1983-24/01/1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non GLP (performed 1983), OECD conform, but experiment was stopped before all animals recovered

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

observation period terminated at day 7 although one animal still showed symptoms

GLP compliance:

no

Specific details on test material used for the study:

- Physical state: liquid
- Lot/batch No.: EN 65360.22.368
- Expiration date of the lot/batch: 12/1983
- Storage condition of test material: room temperature

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2 - 3 kg
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland) ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 4 d
-Individual Identification: ear numbers

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye untreated

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL

Duration of treatment / exposure:

single exposure

Observation period (in vivo):

7 d

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM:
-CORNEA: non irritant = 0; slightly irritant = 1; irritant = 2; severely irritant = 3-4; corrosion = +
-IRIS: non irritant = 0; irritant = 1; severely irritant = 2; corrosion = +
-CONJUNCTIVEAE: non irritant= 0; slightly irritant = 1; irritant = 2; severely irritant = 3; corrosion = +
-CHEMOSIS: no swelling = 0; slight swellinig = 1; swelling = 2; severe swelling = 3-4

TOOL USED TO ASSESS SCORE: no data

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 1, 24, 48, 72 h and 7 d

Score:

0

Max. score:

4

Remarks on result:

other: animal 37/m scored 1 at 1h and reversed to 0 at 24 h

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 1, 24, 48, 72 h and 7 d

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

1.3

Max. score:

3

Reversibility:

not fully reversible within: 7 d

Remarks:

one animal with score of 1 on day 7

Remarks on result:

other: Two animals fully reversed after 7 days.

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

cornea findings

animal no.	1	2	3
1h	0	0	0
24h	0	0	0
48h	0	0	0
72h	0	0	0

iris findings

animal no.	1	2	3
1h	0	0	0
24h	0	0	0
48h	0	0	0
72h	0	0	0

conjunctivae findings

animal no.	1	2	3
1h	1	2	2
24h	2	2	1
48h	2	1	1
72h	1	1	1
7 days	0	0	1

chemosis

animal no.	1	2	3
1h	1	0	1
24h	1	0	1
48h	1	0	1
72h	0	0	1
7 days	0	0	0

Interpretation of results:

GHS criteria not met

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

The findings observed in the two studies do not meet the criteria for classification and labelling as an irritant according to Directive (EC) No 1272/2008.