Disodium wolframate

Endpoint summary

Description of key information

Skin irritation: non-irritating to the skin of New Zealand White rabbits covered with semi-occlusive dressing for 4 hours (GLP and OECD 404 "Acute Dermal Irritation/Corrosion").

Eye Irritation: slightly irritating to the eyes of New Zealand White rabbits after a single instillation (GLP and OECD 405 "Acute Eye Irritation/Corrosion").

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

Remarks:

The study was conducted according to the OECD Guideline for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion".

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, England.
- Age at study initiation: 10 to 12 weeks
- Weight at study initiation: 2.2 to 2.8 g
- Housing: Individually in stainless steel cages with perforated floors.
- Diet: Standard laboratory diet STANRAB (P) SQC Rabbit Diet was provided ad libitum.
- Water: Drinking water was provided ad libitum.
- Acclimation period: Yes


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 22.5
- Humidity (%): 36 to 58%
- Air changes (per hr): 19/hr
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: Distilled water

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:

~ 4 hours.

Observation period:

~60 minutes after removal of the dressing,
Days 24, 48, and 72 hours.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 100 mm x 100 mm
- Type of wrap if used: "Elastoplast" elastic adhesive dressing.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with warm water.
- Time after start of exposure: Immediately after end of exposure period.


SCORING SYSTEM: Animals were scored based on the scoring system presented at each observation point.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

No skin reactions were observed throughout the observation period.

Other effects:

No animals displayed any signs of ill health or toxicity throughout the observation period.

Interpretation of results:

GHS criteria not met

Conclusions:

There were no signs of toxicity or ill health in any rabbit during the observation period.
No dermal response to treatment was observed in any animal throughout the study.

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

Study period:

1998-03-16 to 1999-09-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study was conducted according to OECD Guideline for Testing of Chemicals No. 405: "Acute Eye Irritation/Corrosion". Statement of Compliance with Good Laboratory Practice Standards and Quality Assurance Statement included.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Ltd, Bicester, Oxon, England
- Age at study initiation: 11 to 13 weeks
- Weight at study initiation: 2.6 to 3.0 kg
- Housing: Individually in metal cages with perforated floors.
- Diet: Standard laboratory diet STANRAB (P) SQC Rabbit Diet was provided ad libitum.
- Water: Drinking water was provided ad libitum.
- Acclimation period: yes, no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5 to 20 C
- Humidity (%): 42 to 57%
- Air changes (per hr): 19/hr
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

other: contralateral eyes of each animal served as controls

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

Single instillation with no rinsing or removal.

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

TOOL USED TO ASSESS SCORE: Observation of the eyes was aided by a hand held light.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

probability of weak irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

probability of weak irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.67

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

probability of weak irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

probability of weak irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

probability of weak irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

probability of weak irritation

Irritant / corrosive response data:

No corneal damage of iridial inflammation was observed.
A diffuse crimson coloration of the conjuctivae with partial eversion of the eyelids was seen in one animal. Transient hyperaemia of blood vessels with slight swelling was observed in the remaining two animals. These reactions had resolved by either two or three days after instillation.

Other effects:

There were no signs of toxicity or ill health in any rabbit during the observation period.

Interpretation of results:

GHS criteria not met

Conclusions:

Instillation of the test substance into the rabbit eye elicited transient, very slight to well-defined conjunctival irritation.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Only minimal eye irritation was observed in the conjunctiva of each animal with average scores for 24, 48, and 72 hours below 1 for redness and chemosis, and all effects were reversed by 72 hours. No irritation effects were observed in the cornea or iris up to 72 hours. Therefore, sodium tungstate does not warrant classification as an eye irritant. The mean scores for each skin irritation endpoint at 24, 48, and 72 hours were 0 for each animal. Therefore, sodium tungstate does not warrant classification as a skin irritant.