Reaction products of 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-(C7-C17 odd-numbered, C17-unsatd. alkyl) derivs. and sodium hydroxide and chloroacetic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study meets the EC Standards and is conducted in accordance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Skin corrosivity test described in the US Code of Federal Regulations, title 49, part 173, App. A. Classification system: guidelines of the UN Economic and Social Council (TRANS/GE. 15/R.275, Annex 3, Rev. of Class 8 of RID and ADR, October 1977)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Group of constituents (alkyl derivatives) in Reaction products of 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-(C7-C17 odd-numbered, C17-unsatd. alkyl) derivs. and sodium hydroxide and chloroacetic acid

Molecular formula:

For two representative potential structures: C20H36N2O6Na2 : 446 and C18H35N2O4Na: 367

IUPAC Name:

Group of constituents (alkyl derivatives) in Reaction products of 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-(C7-C17 odd-numbered, C17-unsatd. alkyl) derivs. and sodium hydroxide and chloroacetic acid

Constituent 2

Reference substance name:

Sodium chloride

EC Number:

231-598-3

EC Name:

Sodium chloride

Cas Number:

7647-14-5

Molecular formula:

ClNa

IUPAC Name:

Sodium chloride

Constituent 3

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Oxidane

Test material form:

other: Aqueous solution

Details on test material:

- Physical state: Aqueous solution (viscous yellow liquid)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: A. Smith, 7 Kydcomb Road, Warlingham, Surrey, UK
- Age at study initiation: no data
- Weight at study initiation: 2,3 - 2,8 kg
- Housing: the rabbits were individually housed in grid bottomed metal cages
- Diet (e.g. ad libitum): ad libitum (commercially available pelleted rabbit diet (product ref. 680, Dalgety-Spillers Lmtd))
- Water (e.g. ad libitum): ad libitum (automatic nozzles in each cage)
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 53-65
- Air changes (per hr): no data (air-conditioned)
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Test system

Type of coverage:

occlusive

Preparation of test site:

other: The dorsal surfaces of the trunk were clipped free of hair using an Oster Model A2 clipper with Angra blade

Vehicle:

unchanged (no vehicle)

Controls:

other: No, comparison with adjacent untreated skin

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

4 hr

Observation period:

7 days

Number of animals:

6 females

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: no data
- Type of wrap if used: a strip of 5 cm wide plastic adhesive strapping, this acting as an occlusive barrier

After the 4 hour period of exposure, the dressings were removed and the treated areas gently cleaned using cotton wool soaked in water at 37 degrees Celsius.

SCORING SYSTEM: guidelines of the UN Economic and Social Council (TRANS/GE. 15/R.275, Annex 3, Rev. of Class 8 of RID and ADR, October 1977)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: mean for animals #1, #2, #3, #4, #5 and #6

Time point:

other: Mean value of score at 24, 48 and 72h after patch removal

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 168 hrs in all animals

Remarks on result:

other: Individual mean scores: 0-0.3-0.7-1.7-0.3-0

Results 2

Irritation parameter:

edema score

Basis:

other: mean for animals #1, #2, #3, #4, #5 and #6

Time point:

other: Mean value of score at 24, 48 and 72h after patch removal

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 48 hrs in all animals

Remarks on result:

other: Individual mean scores: 0-0-0.3-0-0.3-0

Other effects:

None reported

Any other information on results incl. tables

Scores:

Animal No	Scores				Mean scores over 24-48-72 hours	Scores
	1 hour	24 hours	48 hours	72 hours		168 hours
Erythema
524	0	0	0	0	0	0
525	1	1	0	0	0.3	0
526	2	1	1	0	0.7	0
530	2	2	2	1	1.7	0
531	0	1	0	0	0.3	0
534	0	0	0	0	0	0
Oedema
524	0	0	0	0	0	0
525	1	0	0	0	0	0
526	1	1	0	0	0.3	0
530	0	0	0	0	0	0
531	2	1	0	0	0.3	0
534	0	0	0	0	0	0

REVERSIBILITY:
Effects reversed by day 7 in all 6 animals

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Not irritating