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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline study (404) For read-across justification refer to section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Tetrasodium ethylenediaminetetraacetate
EC Number:
200-573-9
EC Name:
Tetrasodium ethylenediaminetetraacetate
Cas Number:
64-02-8
IUPAC Name:
tetrasodium 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
Details on test material:
- Lot/batch No.: 03370
- Purity: 75%
- Impurities (identity and concentrations): 8% Na3 Ethylenediaminetriacetic acid, 1.2% Na2 Ethylenediaminetriacetic acid, 3.6% Na3 Nitriloltriacetic acid, < 0.3% Na2 iminodiacetic acid, 2.6% Na-glycolic acid, urotropin
- Expiration date of the lot/batch: April 1984
- Physical state: solid powder

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Diet: Ovator Solikanin; 130 g/day
- Water: tap water ca 250 ml/day
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 30 - 70
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
water
Controls:
other: Untreated skin of the same animal
Amount / concentration applied:
- 0.5 g (80% in water)
Duration of treatment / exposure:
4 h
Observation period:
8 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2 .5 cm X 2 .5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): ones with lutrol and ones with lutrol/water 50%/50%
- Time after start of exposure: 4 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0.4
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Additionally therewas a slight erythema (grade 1) in all animals 30 - 60 min after removal of TS.
Other effects:
No other effects

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information