pentapotassium 2,2’,2’’,2’’’,2’’’’-(ethane-1,2-diylnitrilo)pentaacetate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May-June 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No data on batch number and composition; basic data given, comparable to guidelines/standards

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

yes

Remarks:

slightly other scorig system used than OECD 406 (1992)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Principles of method if other than guideline:

Readings at more time points than required.

GLP compliance:

yes

Remarks:

audited in-house

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

This study was carried out before REACH came into force

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

404-290-3

EC Name:

-

Cas Number:

7216-95-7

Molecular formula:

C14H18K5N3O10

IUPAC Name:

pentapotassium 2-[bis({2-[bis(carboxylatomethyl)amino]ethyl})amino]acetate

Details on test material:

Material was used as delivered.
No data reported on composition and batch number.
Appearance: white powder
Date of receipt: 5 January 1987
Stored at ambient temperature

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: D. Hall, Newchurch, UK
- Age at study initiation: not indicated
- Weight at study initiation: 422-531 g
- Housing: in suspended cages with wire mesh floor and front
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: yes, but duration not indicated


ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 21
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 11 May To: 5 June 1987

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

water

Induction 2

Concentration / amount:

induction:
- intradermal: 1% w/w
- topical: 5% w/w
challenge:
- topical: 0.5 and 0.25% w/w

Challenge

Challenge 1

Route:

epicutaneous, semiocclusive

Vehicle:

water

Challenge 2

Concentration / amount:

induction:
- intradermal: 1% w/w
- topical: 5% w/w
challenge:
- topical: 0.5 and 0.25% w/w

No. of animals per dose:

20 (test group)
10 (control group)

Details on study design:

RANGE FINDING TESTS:
induction:
- intradermal: 1% w/w
- topical: 5% w/w
challenge:
- topical: 0.5 and 0.25% w/w
These levels were also tested in the main study.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1x intradermal, 1x topical
- Exposure period: one week in between
- Test groups: 1
- Control group: 1
- Site: a 4x6 cm area of dorsal skin was clipped free of hair
- Frequency of applications: 3 pairs of intradermal injections, each injection on either side, 1) FCA:water 1:1, 2) test material 1%
w/w in water, 3) test material 1% w/w in FCA:water 1:1, plus a 2x4 patch by topical application
- Duration: single injections and patch for 48 hours
- Concentrations: 1% w/w (injection) and 5% w/w (topical)


B. CHALLENGE EXPOSURE
- No. of exposures: 1x
- Day(s) of challenge: two weeks after topical application
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: 0.5% w/w on one side, 0.25% w/w on other side of the clipped area
- Concentrations: 0.5 and 0.25% w/w
- Evaluation (hr after challenge): 24, 48 and 72 h after challenge

Challenge controls:

Similar to test group.

Positive control substance(s):

no

Results and discussion

Positive control results:

No positive control used.

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.5% and 0.25% w/w

No. with + reactions:

0

Total no. in group:

19

Clinical observations:

localised dermal reaction similar to that in controls

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5% and 0.25% w/w. No with. + reactions: 0.0. Total no. in groups: 19.0. Clinical observations: localised dermal reaction similar to that in controls.

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.5 and 0.25% w/w

No. with + reactions:

1

Total no. in group:

19

Clinical observations:

dermal reactions slightly more marked than in controls

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 and 0.25% w/w. No with. + reactions: 1.0. Total no. in groups: 19.0. Clinical observations: dermal reactions slightly more marked than in controls.

Results 3

Reading:

other: 3rd reading

Hours after challenge:

72

Group:

test chemical

Dose level:

0.5 and 0.25% w/w

No. with + reactions:

1

Total no. in group:

19

Clinical observations:

dermal reactions slightly more marked than in controls

Remarks on result:

other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.5 and 0.25% w/w. No with. + reactions: 1.0. Total no. in groups: 19.0. Clinical observations: dermal reactions slightly more marked than in controls.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

The test material did not induce delayed contact hypersensitivity in 18/19 guinea pigs; in one animal an inconclusive result was
obtained. Overall, it was concluded that the test material is not a skin sensitiser.

Executive summary:

A study was performed to assess the contact sensitisation potential of the test material in the albino guinea pig. The study was performed in compliance with the OECD Test Guideline 406 and Method B6 of EEC Directive 79/831 EEC.

Twenty test and ten control animals were used for the main study. Based on the results of the sighting test, the concentrations of test material for the induction and challenge phases were selected as follows:

lntradermal induction: 1% w/w in distilled water

Topical induction: 5% w/w in distilled water

Topical challenge: 0.5 and 0.25% w/w in distilled water.

Delayed contact hypersensitivity was not seen in 18/19 guinea pigs; one animal showed an inconclusive result.

The test material was classified as a non-sensitiser to guinea pig skin. The test material was also classified as a non-sensitiser according to EU and GHS labelling regulations. No symbol or risk phrase are required.