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Administrative data

Description of key information

Skin irritation

Treatment of the intact rabbit skin with an 80% aqueous preparation of Na4 EDTA resulted in mild or no irritation.

Eye irritation

Irreversible opacity is caused by instillation of undilluted test substance into the eye of rabbits.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Specific details on test material used for the study:
- Lot/batch No.: 03370
- 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
- test material contained 1.64% NaOH
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
Type of coverage:
occlusive
Preparation of test site:
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): once with lutrol and once with lutrol/water 50%/50%
- Time after start of exposure: 4 h

Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.4
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
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
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
Deviations:
yes
Remarks:
dose 50 mg (OECD: volume of 100 mg); 2 animals are used (OECD:3); no washing done (OECD: washing after 1 h), observation period 8 days (OECD: 21)
Principles of method if other than guideline:
BASF-TEST: Before OECD guideline 405 was established, eye irritation was tested using an internal method. White Vienna rabbits were used. Usually approximately 50 mg of the test substance were applied to the conjunctival sac of one eye of 2 animals. In studies with solids, talcum powder was used as control. The animals were observed several times on the treatment day and up to 8 days afterwards, and findings were recorded on working days. The eyes were not washed out after 24 h as specified in OECD Guideline 405, which could be critical for solids which thus remained on the cornea for several days, causing mechanical damage. Probably, this would have been less severe if it had been washed out after 1 day.
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Vehicle:
unchanged (no vehicle)
Controls:
other: talcum powder treated eye of the same animal
Amount / concentration applied:
50 mg
Duration of treatment / exposure:
- unspecified; substance was not washed out
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no washing was done

READING TIME POINTS
10 min, 1 h, 3 h, 24 h, 72 h, 4 d, 7d 8 days after application

READING TIME POINTS USED FOR ASSESSMENT
24 hand 72 h

SCORING SYSTEM:
For the evaluation the BASF scores given in the raw data were converted to Draize scores

Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.8
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritant / corrosive response data:
- The talcum powder treated eye of animal 1 showed conjunctivae score grade 1 after 24 h, this effect was fully reversible within 72 h
- The talcum powder treated eye of animal 2 showed conjunctivae score grade 1 after 24 h and 72 h, this effect was not observable on day 4 - 7 but reappeared on day 8
Other effects:
- during the observation time a grease like layer on the eyes was observed in both animals
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

In a key study which was performed according to OECD guideline 404 the skin of 2 male and 1 female rabbits was exposed to 0.5 g of the test substance for an occlusive exposure period of 4 hours. For erythema medium scores after 24/48/72 hours of 1/0/0.3 were documented, redness had resolved after 8 days. No edema was noted (BASF, 1982).

After treatment of skin of 2 rabbits with Trilon B liquid (CAS 67401 -50 -7; 40% aqueous solution of edetic acid tetrasodium salt) for 1, 5, 15 minutes and 20 hours on the back and for 20 hours on the ear skin readings were performed 24 and 48 h after removal of the test substance. A mild redness (score 0.5) on back and ear of one rabbit after a 20-hour exposure period. Those effects were fully reversible within 48 h. After exposure periods of 15 minutes or less no effects were observed (BASF, 1978).

Eye irritation

Approximately 50 mg of the test substance were applied to the conjunctival sac of one eye of 2 animals. 24 to 72 h after application a mild redness (score 1), mild edema (scale 0.8) and mild opacity (scale 1.3) was present and after 8 days mild redness and mild oedema and mild opacity persisted. During all these observation times a grease-like layer was observed (BASF, 1978). Instillation of 50 mg of of the substance to the eye of one rabbit resulted redness (score 1.75), oedema (score 1.25) and opacity (score 1.3) and pus formation as average 24 -72 h after application. After 8 days a mild opacity was seen (BASF, 1970).



Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for skin irritation/corrosion under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation EC No 2016/1179.

Based on the data, the test substance is classified as Eye Irritant Cat 1 (H318: "Causes serious eye damage") under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation EC No 2016/1179.

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