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Toxicological information

Skin irritation / corrosion

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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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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
- Molecular formula (if other than submission substance): C10 H12 N2 O8 Na4
- Molecular weight (if other than submission substance): 380.17
- Smiles notation (if other than submission substance): [Na]OC(=O)CN(CCN(CC(O[Na])=O)CC(O[Na])=O)CC(O[Na])=O
- InChl (if other than submission substance): InChI=1S/C10H16N2O8.4Na/c13-7(14)3-11(4-8(15)16)1-2-12(5-9(17)18)6-10(19) 20;;;;/h1-6H2,(H,13,14)(H,15,16)(H,17,18)(H,19,20);;;;/q;4*+1/p-4
- Structural formula attached as image file (if other than submission substance): see Fig. 64-02-8 Structure.png

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals 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 there was 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 Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test the substance has not to be classified according to GHS or EU criteria.