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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998-03-02 to 1998-03-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Well documented, scientifically sound study that was conducted in accordance to GLP and OECD guideline 405 with no deviation to the protocol.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium wolframate
EC Number:
234-364-9
EC Name:
Ammonium wolframate
Cas Number:
11120-25-5
Molecular formula:
(NH4)10H2W12O42*4H2O
IUPAC Name:
Ammonium (para)tungstate
Constituent 2
Reference substance name:
Ammonium paratungstate
IUPAC Name:
Ammonium paratungstate
Details on test material:
- Name of test material (as cited in study report): Ammonium Paratungstate
- Physical state: White powder
- Analytical purity: >99.9%
- Storage condition of test material: Room temperature

Test animals / tissue source

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: 10 to 16 weeks
- Weight at study initiation: 2.3 to 3.6 kg
- Housing: Individually in metal cages with perforated floors.
- Diet (eg ad libitum): STANRAB (P) SQC Rabbit Diet ad libitum
- Water (eg ad libitum): ad libitum
- Acclimation period: Acclimated, but period not stated.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 22.5
- Humidity (%): 38 to 65%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12 artificial light (0700 - 1900 hours)

IN-LIFE DATES: From: 1998-03-02 To: 1998-03-23

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
- In compliance with the study guideline, the weight of the test substance, which when gently compacted occupied a volume of 0.1 mL, was measured: 219, 205, 218 mg (Weight of 0.1 mL test material (mg)).
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Details on study design:
- The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial or conjunctival inflammation.
- One animal was treated in advance of the others, to ensure that if a severe response was produced, no further animals would be exposed.
- In compliance with the study guideline, the weight of the test substance, which when gently compacted occupied a volume of 0.1 mL, was measured.
- A volume of 0.1 mL of test substance exceeded 100 mg, therefore in accordance with the protocol 100 mg was placed into the lower inverted lid of one eye of each animal.
- The eyelid was then gently held together for one second before releasing. The contralateral eye remained untreated.

OBSERVATIONS:
- Clinical Signs: All animals were observed daily for signs of ill health or toxicity.
- Ocular Responses: Examination of the eyes was made after 1 hour and 1, 2 and 3 days after instillation (approximately 24, 48 and 72 hours). Additional observations were made 4 days after instillation in two animals and 5 through 21 days after instillation in one animal.
SCORING SYSTEM: Ocular irritation was assessed using the prescribed numerical system with respect to the Cornea, Iris, Conjuctivae and Chemosis.

TOOL USED TO ASSESS SCORE: Handheld light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 21 days
Remarks on result:
probability of weak irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
probability of weak irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
density
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
probability of weak irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.6
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
probability of weak irritation
Remarks:
redness
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
probability of weak irritation
Remarks:
redness
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.6
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
probability of weak irritation
Remarks:
redness
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.6
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
probability of mild irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Corneal opacification (Grade 2) and iridial inflammation (Grade 1) was observed in one animal. Vascularization of the cornea was observed 14 days after instillation. A beefy red colouration of the conjuctivae, swelling with eyelids about half closed and a white discharge was also noted in this animal. Ocular reactions gradually ameliorated and the eye was normal 21 days after instillation.

Responses in the remaining two animals were transient in nature and confined to a diffuse crimson colouration to the conjuctivae, with above normal swelling of the eyelids in one of the rabbits. These reactions had resolved by either three or four days after instillation.
Other effects:
Clinical signs: There were no signs of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Instillation of ammonium paratungstate into the rabbit eye elicited corneal opacification, iridial inflammation and considerable conjunctival irritation in one animal. Reactions in the two remaining rabbits were confined to transient well-defined conjunctival irritation only.

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