Ethanol, 2,2'-iminobis-, N-(C13-15-branched and linear alkyl) derivs.

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Open application, 72 h observation is missing

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethanol, 2,2'-iminobis-, N-(C13-15-branched and linear alkyl) derivs.

EC Number:

308-208-6

EC Name:

Ethanol, 2,2'-iminobis-, N-(C13-15-branched and linear alkyl) derivs.

Cas Number:

97925-95-6

Molecular formula:

Not applicable - multiconstituent substance

IUPAC Name:

Ethanol, 2,2'-iminobis-, N-(C13-15-branched and linear alkyl) derivs.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex, UK
- Weight at study initiation: 2.5-3.0 kg
- Housing:In satinised aluminium steel cages (605 mm width x 490 mm depth x 455 mm height) with one animal per cage
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20
- Humidity (%): 50-60

Test system

Type of coverage:

open

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100%

Duration of treatment / exposure:

3 minutes

Observation period:

Immediately after washing and 2, 24, 48 and 96 h after treatment

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: Whole flank

REMOVAL OF TEST SUBSTANCE
- Washing (if done): By gentle swabbing with cotton wool soaked in lukewarm water
- Time after start of exposure: 3min

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: average 24 and 48h

Score:

2.5

Max. score:

4

Reversibility:

not fully reversible within: 96h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: average 24 and 48h

Score:

2.5

Max. score:

4

Reversibility:

not fully reversible within: 96h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: average 24 and 48h

Score:

3.5

Max. score:

4

Reversibility:

not fully reversible within: 96h

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

other: average 24 and 48h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 96h

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

other: average 24 and 48h

Score:

2.5

Max. score:

4

Reversibility:

not fully reversible within: 96h

Results 6

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

other: average 24 and 48h

Score:

2.5

Max. score:

4

Reversibility:

not fully reversible within: 96h

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: average 24 and 48h

Score:

3.5

Max. score:

4

Reversibility:

fully reversible within: 96h

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: average 24 and 48h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 96h

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: average 24 and 48h

Score:

3.5

Max. score:

4

Reversibility:

fully reversible within: 96h

Results 10

Irritation parameter:

edema score

Basis:

animal #4

Time point:

other: average 24 and 48h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 96h

Results 11

Irritation parameter:

edema score

Basis:

animal #5

Time point:

other: average 24 and 48h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 96h

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

other: average 24 and 48h

Score:

3.5

Max. score:

4

Reversibility:

fully reversible within: 96h

Irritant / corrosive response data:

All animals showed signs of necrosis nintety-six hours after application; these included, typically, thickening of the skin at the application site, eschar formation and blanching and one animal had darkened skin at the appliction site (see table 2).

Any other information on results incl. tables

Table 1: Corrosive reactions

Number of animals with corrosion/all tested animals after
3min	24h	48h
0/6	0/6	1/6

Table 2: Skin corrosion parameters

	Thickened skin after			Blanched skin after			Hardened skin after			Darkened skin after
Animal number	24h	48h	96h	24h	48h	96h	24h	48h	96h	24h	48h	96h
1	-	-	+	-	-	-	-	-	-	-	-	-
2	-	-	+	-	-	-	-	-	-	-	-	-
3	-	+	+	-	-	-	-	+	+	-	+	+
4	-	+	+	-	-	-	-	-	-	-	-	-
5	-	+	+	-	-	+	-	-	-	-	-	-
6	-	+	+	-	-	-	-	-	-	-	-	-

	Cracked skin after			Wrinkled skin after			Eschar formation after
Animal number	24h	48h	96h	24h	48h	96h	24h	48h	96h
1	-	-	-	-	-	-	-	-	-
2	-	-	-	-	-	-	-	-	-
3	-	-	-	-	-	-	-	+	+
4	-	-	-	-	-	-	-	-	-
5	-	-	-	-	+	-	-	-	-
6	-	-	-	-	-	-	-	-	-

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

Undiluted Synprolam 35x2 when administered to rabbit skin for 3 min is corrosive to one out of 6 animals after 48h observation time and 6 out of 6 animals after 96 h observation time and therefore is classified:
CLP: Category 1B, H314 (causes severe skin burns)