Poly(oxy-1,2-ethanediyl), .alpha.-[3-[(carboxymethyl)methylamino]-2-hydroxypropyl]-.omega.-(4-nonylphenoxy)-, sodium salt (1:1)

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July-August 1978

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: No data on batchno. and limited info on composition. Limited reported study according to standard/guideline (max score can be 2).

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

observation 24 h after patch removal and not also after 48 h

Principles of method if other than guideline:

During the induction phase it has been stated that 0.5 ml test agent was emulsified with 0.05 ml Freund's adjuvant. This should read 0.05 ml test agent plus 0.05 ml Freund's adjuvant.

GLP compliance:

no

Remarks:

pre-GLP

Type of study:

guinea pig maximisation test

Test material

Test material information

Constituent 1

Reference substance name:

disodium 2-({2-hydroxy-3-[2-(4-nonylphenoxy)ethoxy]propyl}(methyl)amino)acetate 2-{[3-({1-chloro-3-[2-(4-nonylphenoxy)ethoxy]propan-2-yl}oxy)-2-hydroxypropyl](methyl)amino}acetate

EC Number:

616-248-3

Cas Number:

75627-31-5

Molecular formula:

UVCB not applicable

IUPAC Name:

disodium 2-({2-hydroxy-3-[2-(4-nonylphenoxy)ethoxy]propyl}(methyl)amino)acetate 2-{[3-({1-chloro-3-[2-(4-nonylphenoxy)ethoxy]propan-2-yl}oxy)-2-hydroxypropyl](methyl)amino}acetate

Details on test material:

Name of test compound: TL 856
Appearance: clear viscous liquid
Date of receipt: July 1978
Composition:
- mixture of non ionic and amphoteric surfactants (ca. 60% a.s)
- remainder: water and propylene glycol

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Porcellus Animals Ltd., UK
- Age at study initiation: no info
- Weight at study initiation: 300-400 g
- Housing: 5 to a cage
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: no info


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no info
- Humidity (%): no info
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): no info


IN-LIFE DATES: no info

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

water

Induction 2

Concentration / amount:

Intradermal induction: 0.1 ml test compound 10% (v/v)
Topical induction: 10% v/v on patch
Topical challenge: 10% v/v on patch

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

water

Challenge 2

Concentration / amount:

Intradermal induction: 0.1 ml test compound 10% (v/v)
Topical induction: 10% v/v on patch
Topical challenge: 10% v/v on patch

No. of animals per dose:

10 in test group
5 in control group

Details on study design:

RANGE FINDING TESTS: using 2 guinea pigs the following levels were tested for irritation: 2, 5, 10 and 20% v/v. The test compound was moderately irritant at 20%. Therefore 10% v/v was chosen as challenge concentration.


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (1st intradermal, 2nd topical)
- Exposure period: single injection plus topical application for 48 h (6 days after injection)
- Test groups: test compound
- Control group: Freund's adjuvant only
- Site: 4x6 cm across the scapular region
- Concentrations: 10% v/v (injection), 10% v/v (topical)


B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after last induction
- Exposure period: 24 h
- Test groups: 10% v/v
- Control group: 10% v/v
- Site: right flank
- Concentrations: 10% v/v
- Evaluation (hr after challenge): 24 h after patch removal


OTHER:

Challenge controls:

yes

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

10% v/v at challenge

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

none

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% v/v at challenge. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

At a non-irritant concentration of 10% v/v in water, the test compound was not a sensitiser.

Executive summary:

A study was performed to assess the contact sensitisation potential of the test material in the Dunkin-Hartley guinea pig. The study, a Guinea Pig Maximization Test, was essentially performed in compliance with the requirements of OECD 406. Ten test and five control animals were used for the main study. Based on the results of a sighting test using 2 guinea pigs, the concentration of the test compound for the induction and challenge phases were selected as follows: 10% v/v in water. This concentration was not-irritating, the next higher tested concentration of 20% v/v was moderately irritating. No reactions were observed in both test and control group. The test material, TL 856, was therefore considered a non-sensitiser to guinea pig skin.