Reaction products of diphenylamine with nonene, branched

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Dec 2019 - Feb 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

July 28, 2015

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Landesanstalt für Umwelt Baden-Württemberg

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of Benzeneamine, N-phenyl- with nonene (branched)

EC Number:

701-385-4

Cas Number:

36878-20-3

Molecular formula:

C21H29N - C30H47N (main constituents)

IUPAC Name:

Reaction products of Benzeneamine, N-phenyl- with nonene (branched)

Test material form:

liquid: viscous

Details on test material:

100 g/100 g (UVCB substance)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
-Test item No.: 12/0227-2
- Batch No.of test material: 0016046440
- Expiration date of the lot/batch: January 07, 2020
- Purity: 100 g / 100 g (UVCB substance)

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature; avoid temperature < 10°C
- The stability of the test item under storage conditions over the test period was guaranteed by the sponsor
- Solubility and stability of the test substance in the solvent/vehicle: The test item was homogeneous by visual inspection

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Undiluted applicaton

OTHER SPECIFICS:
- Density [g/mL]: 0.960 (dertermined by testing facility)
- Physical state/ color: Liquid, viscous / yellowish to pink, clear
- pH-value: Approx. 5.5 (undiluted test item, determined by testing facility)

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

Crl:KBL(NZW) – (SPF)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: Approx. 6 months
- Weight at study initiation: 4.03 kg – 4.44 kg
- Sex: Males
- Housing: Single housing in stainless steel wire mesh cages with grating with shallow cage body; floor area: 4225 cm². The animals were housed in fully air-conditioned rooms
- Diet (e.g. ad libitum): STANRAB (P) SQC; SDS Special Diets Services, 67122 Altrip, Germany, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: At least 5 days before application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30 – 70%
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites of the same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Undiluted test substance

Duration of treatment / exposure:

Exposure for 4 hours

Observation period:

up to day 21

Number of animals:

3 animals

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: The test substance was covered with a test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull® stretch (adhesive fleece), Beiersdorf AG

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Lutrol® and Lutrol®/water (1 : 1).
- Time after start of exposure: 4h

OBSERVATION TIME POINTS
- Readings at 24, 48 and 72 h

SCORING SYSTEM:
According to OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72 h

Score:

1.1

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Mean scores over 24, 48 and 72 hours for each animal were 0.0, 2.0 and 1.3 for erythema and 0.0, 0.0 and 0.0 for edema, respectively.
The cutaneous reactions were reversible in one animal within 24 hours, in a second animal within 14 days after removal of the patch.
In one animal, the cutaneous reactions were not reversible within 21 days. In this animal, very slight erythema (grade 1) and yellowish discoloration were seen on study day 21.

Other effects:

yellowish discoloration of the application area in some animals

Any other information on results incl. tables

Tab.1: Tabulation of irritant response, data for each individual animal at each observation time as well as calculation of the means

Readings	Animal No.	Erythema	Edema	Additional Findings
0h	1	1	0
	2	1	0
	3	1	0
1h	1	1	0
	2	2	0
	3	2	0
24h	1	0	0
	2	2	0
	3	2	0
48h	1	0	0	yellowish discoloration of the application area
	2	2	0	-
	3	1	0	-
72h	1	0	0	yellowish discoloration of the application area; SD
	2	2	0	yellowish discoloration of the application area
	3	1	0	yellowish discoloration of the application area
7d	1	-	-
	2	2	0	yellowish discoloration of the application area
	3	1	0	yellowish discoloration of the application area
14d	1	-	-	-
	2	0	0	yellowish discoloration of the application area; SD
	3	1	0	yellowish discoloration of the application area
21d	1	-	-	-
	2	-	-	-
	3	1	0	yellowish discoloration of the application area
Mean 24h – 72h	1	0.0	0.0
	2	2.0	0.0
	3	1.3	0.0
Mean	-	1.1	0.0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Considering the described cutaneous reactions as well as the average score for irritation, the test substance does not show a skin irritating potential under the test conditions chosen.

Executive summary:

The potential of the test substance to cause acute dermal irritation or corrosivity was assessed by a single topical application of an amount of 0.5 mL of the test item for 4 hours to the intact skin of three New Zealand White rabbits (stepwise procedure starting with one animal, supplementing two additional animals), using a patch of 2.5 cm x 2.5 cm, covered with semi-occlusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch and at weekly intervals until day 21 at the latest.

The following test item-related clinical observations were recorded during the course of the study:

- Very slight to well-defined erythema (grade 1 to 2)

- Yellowish discoloration of the applications area

The cutaneous reactions were reversible in one animal within 24 hours and in a second animal within 14 days after removal of the patch. In one animal, cutaneous reactions were not reversible within 21 days. In this animal, very slight erythema (grade 1) and yellowish discoloration were seen on study day 21.

Mean scores over 24, 48 and 72 hours for each animal were 0.0, 2.0 and 1.3 for erythema and 0.0, 0.0 and 0.0 for edema, respectively.

Considering the described cutaneous reactions as well as the average score for irritation of the test item, it does not show a skin irritating potential under the test conditions chosen.