Bis(dimethyl-(2-hydroxyethyl)ammonium) 1,2-ethanediyl-bis(2-hexadecenylsuccinate)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 June 1995 to 4 July 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Bis(dimethyl-(2-hydroxyethyl)ammonium) 1,2-ethanediyl-bis(2-hexadecenylsuccinate)

EC Number:

421-660-1

EC Name:

Bis(dimethyl-(2-hydroxyethyl)ammonium) 1,2-ethanediyl-bis(2-hexadecenylsuccinate)

Molecular formula:

Hill formula: C50 H96 N2 O10 CAS formula: C42 H74 O8. 2(C4 H11 N O)

IUPAC Name:

bis((2-hydroxyethyl)dimethylazanium) (4E)-3-{[2-({3-carboxylato-3-[(2E)-hexadec-2-en-2-yl]propanoyl}oxy)ethoxy]carbonyl}-4-methyloctadec-4-enoate

Constituent 2

Reference substance name:

BIS(DIMETHYL-(2-HYDROXYETHYL)AMMONIUM) 1,2-ETHANEDIYL-BIS (2-HEXADECENYLSUCCINATE)

IUPAC Name:

BIS(DIMETHYL-(2-HYDROXYETHYL)AMMONIUM) 1,2-ETHANEDIYL-BIS (2-HEXADECENYLSUCCINATE)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.45 - 2.67 kg
- Housing: Supended metal cages
- Diet (e.g. ad libitum): Free access
- Water (e.g. ad libitum): Free access
- Acclimation period: Five days minimum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 24
- Humidity (%): 45 - 59
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light


IN-LIFE DATES: NDA

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): N/A


VEHICLE
- Amount(s) applied (volume or weight with unit): N/A (no vehicle used)
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

6 - 3 male and 3 female

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: NDA
- Type of wrap if used: TUBIGRIP


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material removed by gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: Four hours after application


SCORING SYSTEM: Draize Scheme

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hr

Score:

0.7

Max. score:

2

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hr

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Irritant / corrosive response data:

See table below for raw data.
Reversibility of any observed effect: Changes fully reversible within 7 days

Other effects:

Scores of 1 or 2 for erythema/eschar and 1 for oedema were
noted in all animals at 1 hour. Desquamation (considered to
be reversible) was noted on 4 of 6 rabbits at 7 days.

Any other information on results incl. tables

Skin reaction	Observation Time	Individual Scores – Rabbit Number and Sex (Bodyweight kg)						Total
		53 Male (2.51)	9 Male (2.45)	24 Female (2.53)	33 Female (2.53)	62 Male (2.67)	81 Female (2.64)
Erythema / Eschar Formation	1 Hour	1	2	2	2	1	1	9
	24 Hours	1	1	1	1	1	1	6
	48 Hours	1	1	0	1	1	0	4
	72 Hours	1	0	0	1	1	0	3
	7 Days	0D	0	0	0D	0D	0D	0
Oedema	1 Hour	1	1	1	1	1	1	6
	24 Hours	0	0	0	0	0	0	0
	48 Hours	0	0	0	0	0	0	0
	72 Hours	0	0	0	0	0	0	0
	7 Days	0	0	0	0	0	0	0
Sum of 24 and 72- hour Readings (S)    :    9
Primary Irritation Index (S/12)               :    9/12 = 0.75
Classification                                              :    Mild irritant

D = desquamation (considered reversible)

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material, OS 114451A, produced a primary irritation index of 0.75 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme.

Executive summary:

In a primary dermal irritation study (525/034),male and female New Zealand White rabbitswere dermally exposed to 0.5 mL of neat OS 114451A for 4 hours to a 2.5 x 2.5 cm area of skin.  Animals then were observed for 3 days.  Irritation was scored by the method of the Draize classification scheme.

 

All effects observed were reversible within the duration of the study period. Desquamation, which was considered to be reversible, was noted at four treated skin sites at the 7 day observation.In this study, OS 114451A is not classified as a dermal irritant.