Pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

ca. 1983

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 (max reliability score can be 2)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Lack of detail on test material (batch number and composition) and age/source of animals. Number of air changes also not mentioned

Principles of method if other than guideline:

Method used described in 'Appraisal of the safety of chemicals in foods, drugs and cosmetics', by the staff of the division of
pharmacology, food and drug administration. Primary irritation score by J.H. Draize (1959).
Test substance was also tested on abraded skin.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate

EC Number:

205-391-3

EC Name:

Pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate

Cas Number:

140-01-2

Molecular formula:

C14H23N3O10.5Na

IUPAC Name:

.

Details on test material:

Yellow turbid liquid, supplied by Akzo Chemie LW, Amersfoort, the Netherlands
Test substance was applied undiluted.
pH value: 12.53

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not indicated
- Age at study initiation: not indicated
- Weight at study initiation: 2.4-2.6 kg
- Housing: individually
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: not indicated


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 45-55
- Air changes (per hr): not indicated.
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: not indicated.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and one side also abraded

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): undiluted

Duration of treatment / exposure:

4 h

Observation period:

up to 72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: on the back
- % coverage: two squares of 2.5 cm
- Type of wrap if used: patches consisted of double layer light gauze; the trunks was wrapped in a rubber sleeve and the animals were immobilized in restrainers


REMOVAL OF TEST SUBSTANCE
- Washing (if done): not indicated
- Time after start of exposure: 4 hours


SCORING SYSTEM: according to Draize (1959). Readings were made immediately after removal of the patches, and 24 and 72
hours thereafter. The cumulative scores 4/24 hours and 72 hours (erythema and oedema) were averaged for bot abraded and
intact skin and added together to calculate the primary irritation index.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 4/24 hours and 72 hours

Score:

0

Reversibility:

other: no irritation at all

Remarks on result:

other: all 3 animals had score: 0

Irritant / corrosive response data:

No irritation

Other effects:

Not indicated

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is not a skin irritant

Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used was essentially according to the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irri tation/Corrosion" A single 4 -hour, occluded application of the test material to intact and abraded skin of three rabbits produced no erythema or oedema. All treated skin sites appeared normal at the 4/24 -hour and 72 -hour observation. The test material produced a primary irritation index of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. The test material did not meet the criteria for classification as irritant or corrosive according to OECD-GHS labeling regulations. No symbol and risk phrase are required.