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Diss Factsheets

Administrative data

Description of key information

Taking into account all available data, N-phenyl-1-naphthylamine was found not to be irritating to the skin.

Under the experimental conditions, the test material was not considered to be an eye irritant since slight conjunctivitis was fully reversible within 10 days.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
The experiments reported herein were conducted according to the "Guide for the Care and Use of Laboratory Animals", DHEW 78-23. Rabbits were tested according to the methods described by Draize et al., (1944) to determine primary skin irritation potential for the test material.
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.0-3.0 kg
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Duration of treatment / exposure:
no data
Observation period:
24 and 72 hours
Number of animals:
6
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Remarks on result:
other: no irritation effects

24 and 72 hour postexposure examinations of animals tested with N-phenyl-α-naphthylamine failed to demonstrate any irritation effects in the intact skin. There was no evidence of erythema or eschar formation which would be indicative of primary irritation.

Interpretation of results:
other: EU GHS criteria not met
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study (OECD), but intended for evaluation for skin sensitization
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 406
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EU Method B.6
Deviations:
no
Principles of method if other than guideline:
This test was a preliminary test intended to find the Pre-Maximum Non Irritant Concentration (M.N.I.C.) for the main skin sensitization study (7.4.1 Richeux, 203).
GLP compliance:
yes (incl. QA statement)
Species:
guinea pig
Strain:
Dunkin-Hartley
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Centre de Production Animale (F-45160 Olivet)
- Weight at study initiation: mean 449.8 g (males), 428.4 g (females)
- Diet (e.g. ad libitum): Guinea Pig Breeding Diet, Cobayes-Elevage
- Acclimation period: 5 day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 26 - 61
Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
other: praffin oil
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no information given
- Concentration (if solution): 12.5%, 25%, 50%, 100%
Duration of treatment / exposure:
24 h
Observation period:
24 h
Number of animals:
2
Details on study design:
This test was a preliminary test intended to find the Pre-Maximum Non Irritant Concentration (M.N.I.C.) for the main skin sensitization study (7.4.1 Richeux, 203).
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
no data
Remarks on result:
other: Concentration: 100%
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: Concentration: 12.5%, 25%, 50%
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: Concentration: 12.5%, 25%, 50%
Irritant / corrosive response data:
24 hours after the removal of the occlusive dressings, it was noted a slight erythema on the treated area at 100%. In view of these results, the concentrations selected were 100% for the 2nd induction of the main study and the MNIC began at the concentration of 50%.

Pre-Maximum Non Irritant Concentration (M.N.I.C.) determination:

Macroscopic evaluation of cutanous reaction:

Animal Concentration (%)
100 50 25 12.5
1 1 0 0 0
2 1 0 0 0
Interpretation of results:
other: EU GHS cirteria not met
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
Primary irritation to the skin is measured by a patch-test technique on the intact skin of albino rabbits.
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
no data
Type of coverage:
occlusive
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 g


Duration of treatment / exposure:
24 hours
Observation period:
24, 72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: backs of the animals
- % coverage: 2.5 cm2 x2.5 cm2
- Type of wrap if used:
The patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped with an impervious material to maintain teh test patechs in position and to retard evaporation of volatile substances.

SCORING SYSTEM: Draize scoring system
Irritation parameter:
erythema score
Basis:
animal: #1, #3, #6
Time point:
other: 24 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: Draize scoring
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
no data
Remarks on result:
other: Draize scoring
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24 hours
Score:
2
Max. score:
4
Reversibility:
no data
Remarks on result:
other: Draize scoring
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24 hours
Score:
1
Max. score:
4
Reversibility:
no data
Remarks on result:
other: Draize scoring
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3, #5, #6
Time point:
other: 24 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: Draize scoring
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24 hours
Score:
2
Max. score:
4
Reversibility:
no data
Remarks on result:
other: Draize scoring
Irritation parameter:
other: scaliness
Basis:
animal: #1, #3, #4, #5, #6
Time point:
other: 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: CIVO scoring
Irritation parameter:
other: scaliness
Basis:
animal #2
Time point:
other: 72 hours
Score:
1
Max. score:
4
Reversibility:
no data
Remarks on result:
other: CIVO scoring

skin irritation scores:

   24 hours 24 hours  72 hours 
 rabbit no.  erythema (Draize scoring) edema (Draize scoring)   scaliness (CIVO scoring)
 1 0  0  0
 2 1  0  1 
 3 0  0  0 
 4 2  2  0 
 5 1  0  0 
 6 0  0  0 
Interpretation of results:
other: EU GHS criteria not met
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
N-phenyl-1-napthylamine was applied to the intact skin of rabbits and skin irritation was evaluated after 24 hours after application.
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
other: Carbowax PEG400
Controls:
not specified
Duration of treatment / exposure:
The test material was not removed.
Observation period:
24 hours
Number of animals:
5
Irritation parameter:
other: The test material was slightly irritating to the skin.
Remarks on result:
other: 24 hours after application: moderate capillary injection on 2 rabbits, marked injection on 3 rabbits. Therefore, the test material was slightly irritating to the skin.
Conclusions:
24 hours after application: moderate capillary injection on 2 rabbits, marked injection on 3 rabbits. Therefore, the test material was slightly irritating to the skin.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 JUN 1987 to 26 JUN 1987
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:
1981
GLP compliance:
no
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- 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: 2680 to 3100 g
- Housing: individually in metal cages
- Diet: ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: the patches were moistened before application with distilled water containing 0.5% carboxymethylcellulose and 0.1% polysorbate 80
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
Duration of treatment / exposure:
4 hours
Observation period:
3 days
Number of animals:
3 male rabbits
Details on study design:
TEST SITE
- Area of exposure: flank
- Type of wrap if used: aluminum foil (36 cm ) held in place for 4 hours by an adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: after 4 hours

OBSERVATION TIME POINTS
1, 24, 48, and 72 hours after removing the gauze patches

SCORING SYSTEM:
- Method of calculation: OECD scoring system
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Slight erythema and edema reactions (score 1) were observed one hour after removing the bandages in one animals. All other readings at 24, 48 and 72h timepoints in all animals were zero.
Other effects:
A slight loss of weight was observed in one animal at the end of the observation period on day 3.
Interpretation of results:
other: EU GHS criteria not met
Conclusions:
Under the experimental conditions employed the test item induced slight erythema and edema reactions when applied to the clipped albino rabbit skin. The reactions were observed only one hour after removing the bandages. Because the mean values of the recordings 24 to 72 hours after application are scored zero, the test item is considered to be not irritating to the skin.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
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
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: approx. 12-14 weeks
- Weight at study initiation: 2510 to 2520 g
- Housing: The animals were housed individually in metal cages.
- Diet (e.g. ad libitum): standard rabbit pellet (Nafag No. 814, Switzerland); ad libitum; All batches of the diet are assayed for nutritive ingredients and contaminant level by the manufacturer.
- Water (e.g. ad libitum): fresh water; ad libitum; The quality of the drinking water was according to the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972).
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: The right eyes of the test animals were used as controls.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (36 mg)
Duration of treatment / exposure:
The test material was not removed.
Observation period (in vivo):
1, 24, 48 and 72 hour(s) after the instillation of test material.
Number of animals or in vitro replicates:
3 female rabbits
Details on study design:
SCORING SYSTEM: OECD scoring system
TOOL USED TO ASSESS SCORE: slit lamp
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritant / corrosive response data:
All control eyes were negative.
After 1 hour, chemosis was observed in animal #2 and animal #3, but was fully reversible within 24 hours.
Under the experimental condition, the test material was classified as not irritating to eyes.
Other effects:
A slight loss of body weight was observed in animal #2 on day 3 (table 1).

Table 1: body weights in g

 animal no.  #1 #2  #3 
 at start of test  2510 2510  2520 
 after 3 days 2550  2460  2620 
 after 7 days 2680  2610  2730 
 after 10 days (end) 2800  2600 (not clear because of the bad copy of the report)  2880
Interpretation of results:
other:
Remarks:
EU GHS criteria not met
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
other: FDA of the United States (Fed. Reg. 28 (119), 5582, 1963)
Principles of method if other than guideline:
The techniques of the test are published by the FDA of the United States (Fed. Reg. 28 (119), 5582, 1963) and Draize and Kelley (Drug Cosmet. Industr. 71 (36), 1952).
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
no data
Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye of the test animals serves as a control.
Duration of treatment / exposure:
The test material was not removed.
Observation period (in vivo):
24, 48, 72 hours and 7 days
Number of animals or in vitro replicates:
6
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #5, #6
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 24, 48, 72 hours
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
3
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 24, 48, 72 hours
Score:
> 1
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
other: 24, 48, 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
3
Reversibility:
other: no effects
Interpretation of results:
other:
Remarks:
EU GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

The potential of the test substance to cause acute dermal irritation or corrosion was assessed in an in vivo skin irritation study following OECD guideline no. 404 (Ciba-Geig, 1987). A single topical application of 0.5 g of the test substance was administered to the intact skin of 3 New Zealand White rabbits for 4 hours under occlusive dressing. Following removal of the test substance, consecutive readings of the application sites were performed over a period of 72 hours. Untreated skin regions of the same animals served as control. As no skin findings were observed in all animals within 72 hours after removal of the patches, the study was terminated. Under the test conditions chosen and considering the described findings the test compound does not give indication of an irritant property to the skin. Several supporting studies are available showing that the test item has no adverse irritation potential.

Eye irritation

In an OECD 405 guideline compliant study the ocular irritation potential of N-phenyl-1-naphthylamine was determined by instillation of the test material into the conjunctival sac of rabbits. Slight conjunctivitis was observed in 2 of 3 rabbits, but was fully reversible within a maximum of 10 days (Ciba-Geigy, 1987). In a study conducted according to US FDA standards, 24 hours after the test compound had been brought into the eyes of rabbits, slight conjunctivitis was observed in 4 of 6 rabbits and chemosis in 1 of 6 rabbits. After 7 days all eye lesions had recovered completely (TNO, 1977).

Justification for classification or non-classification

Data on skin and eye irritation are conclusive but not sufficient for classification.