[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 January 2014 - 19 March 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The study was conducted to obtain safety data required for updating the product.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

the test substance was applied occlusively (according to OECD: semi-occlusive), results can be regarded as worst case.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1-Propanol, 2-methyl-, reaction products with 1,5-diisocyanatopentane

Cas Number:

1357171-37-9

Molecular formula:

not applicable (a generic formula cannot be provided for this UVCB substance)

IUPAC Name:

1-Propanol, 2-methyl-, reaction products with 1,5-diisocyanatopentane

Test material form:

liquid: viscous

Details on test material:

- Physical appearance: pale yellow viscous liquid
- Storage conditions: at room temperature and in nitrogen atmosphere

Test animals

Species:

rabbit

Strain:

other: Kbl: JW

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Minowa Production Site of Kitayama Labs Co.
- Age at study initiation: 19 weeks old
- Weight at study initiation: not indicated
- Housing: in a breeding room
- Diet: approx. 130 g/day/animal pelleted diet for rabbits (LRC4 from Oriental Yeast Co., Ltd.)
- Water: filtered tap water (Mobara City Water), ad libitum
- Acclimation period: 3 weeks

ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 23 ± 2
- Humidity (%): 55 ±20
- Air changes (per hr): 10 or more
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: not indicated

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

Test item: 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

9 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal skin
- Area covered: exposure via lint of 2.5 by 2.5 cm
- Type of wrap if used: the application site was sealed with surgical tape (BlendermTM available from 3M) and further fixed with an adhesive elastic bandage (Benefact Beige No.4, available from Nippon Sigmax Co.).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, the test item was lightly wiped off with absorbent cotton wetted with lukewarm water.
- Time after start of exposure: 4 hours (directly after removal of the test item)

OBSERVATION TIME POINTS: once a day for 9 days (except on Saturdays, Sundays and holidays). Since all effects were fully reversed after 9 days, the observation period was not prolonged after day 9.

SCORING SYSTEM: according to the Draize scoring system
- Method of calculation of Primar Irritation Index (PII): PII was calculated by dividing the total points of “erythema and eschar formation” and “edema formation” at 24, 48 and 72 hours after removal of application by 9 (3 points x number of used animal).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 9 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

In one animal, erythema of score 1 to 2 was observed at 1 to 72 hours, but it disappeared 6 days after removal of the application. In the second animal, erythema of score 1 was observed at 1 to 48 hours, but it disappeared at 72 hours after removal of application.
In animal No. 3, erythema of score 1 to 2 was observed at 1 hour to 8 days, and edema of score 1 was observed at 24 hours after removal of application. Erythema disappeared at 9 days and edema disappeared at 48 hours after removal of application in animal number 3.
Individual mean scores were 1.33, 0.67 and 2.00 in animals No. 1, 2 and 3 respectively, and skin primary irritation index was 1.33.

Other effects:

During the entire test period, no abnormality was observed in the test animals.

Any other information on results incl. tables

Table 1 Results of observation of skin reactions

Test substance	Animal No.		Hourse after removal of application				Days after removal of application				Individual mean score	Skin primary irritation index
			1	24	48	72	6	7	8	9
D-370N	1	Erythema and eschar formation	1	2	1	1	0	-	-	-	1.33	1.33
		Edema formation	0	0	0	0	0	-	-	-
		Other skin changes	N	N	N	N	N	-	-	-
	2	Erythema and eschar formation	1	1	1	0	-	-	-	-	0.67
		Edema formation	0	0	0	0	-	-	-
		Other skin changes	N	N	N	N	-	-	-	-
	3	Erythema and eschar formation	1	2	2	1	1	1	1	0	2.00
		Edema formation	0	1	0	0	0	0	0	0
		Other skin changes	N	N	N	N	N	N	N	N

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to Regulation (EC) 1272/2008

Conclusions:

In an in vivo skin irritation study performed in accordance with OECD 404, only minimal skin effects were seen after treatment with D-370N. based on these results, D-370N is not classified for skin irritation/corrosion according to Regulation (EC) 1272/2008 on CLP.

Executive summary:

An in vivo skin irritation study was performed according to OECD guideline 404 to assess the skin irritation potential of D-370N. Three rabbits were exposed to the test item on a 2.5 by 2.5 cm area of their dorsal skin for 4 hours. The skin was treated in an occlusive manner. After the exposure period, daily observations for skin irritation were performed for 9 days. After 9 days, all observed skin reactions were fully reversed. Skin irritations were scored according to the Draize system. No abnormalities were observed in the animals during the observation period. Only minimal skin effects were seen. All three animals 3 animals had a mean erythema/eschar or oedema score below 2.3 at 24, 48 and 72 hours. Furthermore, all effects were reversible within 9 days. Therefore, D-370N is not classified for skin irritation/corrosion according to Regulation (EC) 1272/2008 on CLP.