N-(dodecylphenyl)naphthalen-1-amine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 April 1999 to 7 May 1999.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 17 July 1992)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

1

Reference substance name:

-

EC Number:

437-450-6

EC Name:

-

Cas Number:

64654-05-3

Molecular formula:

Hill formula: C28 H37 N

IUPAC Name:

N-(dodecylphenyl)naphthalen-1-amine

Test material form:

liquid: viscous

Details on test material:

Sponsor's identification: APAN
Description: redbrown viscous liquid
Lot number: EL01010B01/KZ8911.5
Storage conditions: room temperature in the dark

Specific details on test material used for the study:

No further details specified in the study report.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Three New Zealand White rabbits supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK were used. At the start of the study the animals weighed 2.68 to 3.01 kg and were twelve to sixteen weeks old. After a minimum acclimatisation period of five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended metal cages. Free access to mains drinking water and food (STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK) was allowed throughout the study.
The temperature and relative humidity were controlled to remain within target ranges of 17 to 23 °C and 30 to 70% respectively. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

At each test site a quantity of 0.5 ml of the test material was introduced.

Duration of treatment / exposure:

One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application.

Observation period:

Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation.

Number of animals:

3

Details on study design:

On the day before the test each rabbit was clipped free of fur from the dorsal flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
One rabbit was initially treated. Three suitable test sites were selected on the back of the rabbit. At each test site a quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm). To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animal was returned to its cage for the duration of the exposure period.
One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application. Any residual test material was removed by gentle swabbing with cotton wool soaked in 74% industrial Methylated Spirits.
After consideration of the skin reactions produced in the first animal, two additional animals were treated with 0.5 ml of test material. One patch was applied to the back of each rabbit, and was allowed to remain in contact with the skin for a period of four hours.
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

4-Hour Exposure Period
Very slight erythema was noted at one treated skin site at the 24 and 48-hour observations. No other signs of dermal irritation were noted during the study.

1-Hour Exposure Period
Very slight erythema was noted at the treated skin site at the 24 and 48-hour observations. The treated skin site appeared normal at the 72-hour observation.

3-Minute Exposure Period
No signs of dermal irritation were noted during the study.

Other effects:

No further effects detailed in the study report.

Any other information on results incl. tables

INDIVIDUAL SKIN REACTIONS FOLLOWING 4-HOUR EXPOSURE PERIOD

Skin Reaction	Observation Time	Individual Scores – Rabbit Number and Sex (Bodyweight kg)			Total
		184 Female (2.78)	170 Female (2.68)	215 Female (3.01)
Erythema/Eschar Formation	1 Hour 24 Hours 48 Hours 72 Hours	0 1 1 0	0 0 0 0	0 0 0 0	(0) 1 (1) 0
Oedema Formation	1 Hour 24 Hours 28 Hours 72 Hours	0 0 0 0	0 0 0 0	0 0 0 0	(0) 0 (0) 0
Sum of 24 and 72-hour Readings (S)	:	1
Primary Irritation Index (S/6)	:	1/6 – 0.2
Classification	:	MILD IRRITANT

( ) – Total values not used for calculation of primary irritation index

 

INDIVIDUAL DAILY AND MEAN SCORES FOR DERMAL IRRITATION FOLLOWING 4-HOUR EXPOSURE REQUIRED

FOR EU LABELLING REGULATIONS

Skin Reaction	Reading (Hours)	Individual Scores – Rabbit Number and Sex (Bodyweight kg)
		184 Female (2.78)	170 Female (2.68)	215 Female (3.01)
Erythema/Eschar Formation	24 48 72	1 1 0	0 0 0	0 0 0
Total		2	0	0
Mean Score		0.7	0.0	0.0
Oedema Formation	24 48 72	0 0 0	0 0 0	0 0 0
Total		0	0	0
Mean Score		0.0	0.0	0.0

 

INDIVIDUAL SKIN REACTIONS FOLLOWING 1-HOUR AND 3-MINUTE EXPOSURES

Skin Reaction	Observation Time	Individual Scores – Rabbit Number and Sex (Bodyweight kg)
		184 Female (2.78)
		1-Hour Exposure	3-Minute Exposure
Erythema/Eschar Formation	1 Hour 24 Hours 48 Hours 72 Hours	0 1 1 0	0 0 0 0
Oedema Formation	1 Hour 24 Hours 48 Hours 72 Hours	0 0 0 0	0 0 0 0

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material, APAN, produced a primary irritation index of 0.2 and was classified as a MILD IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required.

Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 1 7 July 1992) and Method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

 

The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 93/21/EEC) relating to the classification, packaging and labelling of dangerous substances.

 

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema. All treated skin sites appeared normal at the 72-hour observation. No corrosive effects were noted.

 

3-minute and 1-hour semi-occluded applications of the test material to the intact skin of one rabbit produced no corrosive effects.

 

The test material produced a primary irritation index of 0.2 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme.

 

The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations. No symbol and risk phrase are required.