Registration Dossier

Administrative data

Description of key information

Skin Irritation:

A single semi-occlusive application of Ammonium Molybdate to intact rabbit skin for four hours elicited no dermal irritation.

The overall irritation index after 4 days of observation was 0.0.

Hence, Ammonium molybdate can be considered not irritating to skin.

Eye Irritation:

Instillation of Ammonium molybdate into the rabbit eyes elicited transient and very slight conjunctival inflammation only which were completely resolved after 4 days

The overall irritation scores after 7 days was 0.0

Based on the observations and scores, Ammonium molybdate can be considered not irritating to rabbit eyes.

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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from NTRL reports
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
The dermal irritation potential of Ammonium molybdate was assessed in rabbits according to OECD 404 Guidelines
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (as cited in study report): ammonium molybdate(VI)
- Molecular formula: MoO4.2H4N
- Molecular weight: 196.0132 g/mol
- Smiles notation: [Mo](=O)(=O)([O-])[O-].[NH4+].[NH4+]
- InChl: 1S/Mo.2H3N.4O/h;2*1H3;;;;/q;;;;;2*-1/p+2
- Substance type: Inorganic
- Physical state: Solid
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
-Sex: Female
- Source: A. Smith, Warlingham. Surrey
- Age at study initiation: 9 to 12 weeks of age
- Weight at study initiation: 2.2 to 2.7 kg
- Fasting period before study:
- Housing: The rabbits were individually housed in metal cages with perforated floors in Building
- Diet (e.g. ad libitum): SDS Standard Rabbit Diet
- Water (e.g. ad libitum):Tap water
- Acclimation period: The rabbits selected for the study were all acclimated to the laboratory environment


ENVIRONMENTAL CONDITIONS
- Temperature (°C):19 deg C
- Humidity (%):Relative humidity:30-70%
- Air changes (per hr): 19 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hour period.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
0.5 gm
Duration of treatment / exposure:
4 hours
Observation period:
Day 1(approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4.
Number of animals:
6 female rabbits
Details on study design:
TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10 cm square patch
- Type of wrap if used: Elastoplast

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed using water to remove any residual test substance.
SCORING SYSTEM:
Grading and scoring of the dermal reactions were performed using the prescribed numerical scoring system.
Other effects / acceptance of results:
no data available
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No dermal irritation observed

Table: Dermal reactions elicited by Ammonium Molybdate

Rabbit

number

Sex

 

E =Erythema

o =Oedema

Day

1*

2

3

4

1

female

E

0

0

0

0

O

0

0

0

0

2

Female

E

0

0

0

0

O

0

0

0

0

3

Female

E

0

0

0

0

O

0

0

0

0

4

Female

E

0

0

0

0

O

0

0

0

0

5

Female

E

0

0

0

0

O

0

0

0

0

6

Female

E

0

0

0

0

O

0

0

0

0

*-Approximately 30 minutes after removal of dressing

Interpretation of results:
other: not irritating
Conclusions:
A single semi-occlusive application of Ammonium Molybdate to intact rabbit skin for four hours elicited no dermal irritation.
The overall irritation index after 4 days of observation was 0.0.
Hence, Ammonium molybdate can be considered not irritating to skin.
Executive summary:

A study was conducted to assess the irritation potential of ammonium molybdate. The study was conducted as per OECD 404 Guidelines.

0.5 gm of test chemical was applied to the dorso-lumbar region exposing an area of skin approximately 10 cm square under 2.5 cm square gauze pad moistened with 0.5 ml distilled water to one intact skin site of 6 female New Zealand White rabbits.Each treatment site was occluded with Elastoplast elastic adhesive dressing for a four hour period.At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and washed and animal were scored in accordance with edema erythema formation.Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) andon Days 2, 3 and 4.There was no response to treatment in any animal throughout the observation period.A single semi-occlusive application of Ammonium Molybdate to intact

rabbit skin for four hours elicited no dermal irritation.

The overall irritation index after 4 days of observation was 0.0.Hence, Ammonium molybdate can be considered not irritating to skin.

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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
data is from NTRL reports
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
The ocular irritation potential of Ammonium molybdate was assessed in rabbits
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (as cited in study report): ammonium molybdate(VI)
- Molecular formula: MoO4.2H4N
- Molecular weight: 196.0132 g/mol
- Smiles notation: [Mo](=O)(=O)([O-])[O-].[NH4+].[NH4+]
- InChl: 1S/Mo.2H3N.4O/h;2*1H3;;;;/q;;;;;2*-1/p+2
- Substance type: Inorganic
- Physical state: Solid
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: Male
- Source: A. Smith, Warlingham. Surrey
- Age at study initiation: 12 to 13 week
- Weight at study initiation: 2.8 to 3.1 kg
- Fasting period before study:
- Housing: The rabbits were individually housed in metal cages with perforated floors in Building
- Diet (e.g. ad libitum): SDS Standard Rabbit Diet
- Water (e.g. ad libitum):Tap water
- Acclimation period: The rabbits selected for the study were all acclimated to the laboratory environment

ENVIRONMENTAL CONDITIONS
- Temperature (°C):19 deg C
- Humidity (%):Relative humidity:30-70%
- Air changes (per hr): 19 air changes
per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24 hour period.
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
A 100 mg amount of Ammonium molybdate, the weight occupying a volume of 0.1 ml, was placed into the lower everted lid.
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and.7 days after instillation.
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
6 male rabbits
Details on study design:
TEST SITE
- Area of exposure: lower everted lid.

SCORING SYSTEM: Grading and scoring of the ocular lesions were performed according to cornea,iris, Conjunctivae ,chemosis and redness in the eye of rabbit
Grading Scale for Eye Irritation:
Cornea Grade
Opacity: degree of density (readings should be taken from most dense area)*
No ulceration or opacity = 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris slightly obscured = 1*
Easily discernible translucent area; details of iris slightly obscured = 2*
Opalescent area; no details of iris visible; size of pupil barely discernible = 3*
Opaque cornea; iris not discernible through the opacity = 4*
Area of Cornea Involved
One quarter(or less) but not zero = 1
Greater than one quarter, but less than half = 2
Greater than half, but less than three quarters = 3
Greater than three quarters, up to whole area = 4
Iris
Normal = 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light (a sluggish reaction is considered to be an effect = 1 *
Hemorrhage, gross destruction, or no reaction to light = 2*

Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
Vessels Normal = 0
Some blood vessels definitely hyperaemic (injected) = 1
Diffuse, crimson colour; individual vessels not easily discernible = 2*
Diffuse beefy red = 3 *
Chemosis
Swelling (refers to lids and/or nictating membranes)
No swelling = 0
Any swelling above normal (includes nictating membrane)= 1*
Obvious swelling, with partial eversion of lids = 2*
Swelling, with lids about half closed = 3*
Swelling, with lids more than half closed= 4*

*-interpreted as a positive effect (TSCA test criteria)
Other effects / acceptance of results:
no data available
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 4 days
Score:
0
Reversibility:
fully reversible within: 4 days
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
All conjunctival reactions had resolved one to four days after instillation. No corneal or iridial inflammation was seen throughout the observation period . A diffuse crimson-red colouration of the conjunctivae was evident twenty-four hours after instillation only in one animal. Mild conjunctival inflammation was observed in the remaininq animals.

Ocular reactions elicited by Ammonium molybdate:

Rabbit no.

Region of eye

1 hr

Days after installation

1

2

3

4

7

1

Cornea

Density

0

0

0

0

0

0

Area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctivae

Redness

1

2

1

1

0

0

Chemosis

1

1

0

0

0

0

2

Cornea

Density

0

0

0

0

0

0

Area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctivae

Redness

1

1

1

1

0

0

Chemosis

1

0

0

0

0

0

3

Cornea

Density

0

0

0

0

0

0

Area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctivae

Redness

1

1

1

0

0

0

Chemosis

1

1

0

0

0

0

4

Cornea

Density

0

0

0

0

0

0

Area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctivae

Redness

1

1

0

0

0

0

Chemosis

1

0

0

0

0

0

5

Cornea

Density

0

0

0

0

0

0

Area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctivae

Redness

1

0

0

0

0

0

Chemosis

1

0

0

0

0

0

6

Cornea

Density

0

0

0

0

0

0

Area

0

0

0

0

0

0

Iris

0

0

0

0

0

0

Conjunctivae

Redness

1

0

0

0

0

0

Chemosis

1

0

0

0

0

0


Interpretation of results:
other: not irritating
Conclusions:
Instillation of Ammonium molybdate into the rabbit eyes elicited transient and very slight conjunctival inflammation only which were completely resolved after 4 days
The overall irritation scores after 7 days was 0.0
Based on the observations and scores, Ammonium molybdate can be considered not irritating to rabbit eyes.
Executive summary:

The ocular irritation potential of Ammonium molybdate was assessed in rabbits. The study was performed according to OECD 405 Guidelines. 100 mg of 0.1 ml chemical was installed into thelower everted lid of 6 New Zealand White male rabbits. The contralateral eye remained untreated and served as a control. Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and.7 days after instillation. Observation of the eyes was aided by the use of a handheld torch. Grading and scoring of the ocular lesions were performed.

One of the animals gave a "positive" response. No corneal damage or iridial inflammation was seen throughout the observation period. A diffuse crimson-red colouration of the conjunctivae was evident twenty-four hours after instillation only in one animal. Mild conjunctival inflammation was observed in the remaininq animals. All conjunctival reactions had resolved one to four days after instillation.

Instillation of Ammonium molybdate into the rabbit eyes elicited transient and very slight conjunctival inflammation only which were completely resolved after 4 days

The overall irritation scores after 7 days was 0.0

Based on the observations and scores, Ammonium molybdate can be considered not irritating to rabbit eyes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation:

In different studies,Ammonium molybdate has been investigated for potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits for target chemical and for the read across substance, sodium molybdate [CAS: 7631-95-0].

A study was conducted (NTRL submission report -OTS0000811, last updated 1991)to assess the irritation potential of ammonium molybdate. The study was conducted as per OECD 404 Guidelines.

0.5 gm of test chemical was applied to the dorso-lumbar region exposing an area of skin approximately 10 cm square under 2.5 cm square gauze pad moistened with 0.5 ml distilled water to one intact skin site of 6 female New Zealand White rabbits.Each treatment site was occluded with Elastoplast elastic adhesive dressing for a four hour period.At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and washed and animal were scored in accordance with edema erythema formation.Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) andon Days 2, 3 and 4.There was no response to treatment in any animal throughout the observation period.A single semi-occlusive application of Ammonium Molybdate to intact rabbit skin for four hours elicited no dermal irritation.

The overall irritation index after 4 days of observation was 0.0.Hence, Ammonium molybdate can be considered not irritating to skin.

This result is supported by the experimental study summarized in NTRL submission report -OTS0000811, last updated 1991; for the read across substance,sodium molybdate [CAS: 7631-95-0].The study was conducted as per OECD 404 Guidelines.

0.5 gm of test chemical was applied to the dorso-lumbar region exposing an area of skin approximately 10 cm square under 2.5 cm square gauze pad moistened with 0.5 ml distilled water to one intact skin site of 6 female New Zealand White rabbits.Each treatment site was occluded with Elastoplast elastic adhesive dressing for a four hour period.At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and washed and animal were scored in accordance with edema erythema formation.Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) andon Days 2, 3 and 4.There was no response to treatment in any animal throughout the observation period.A single semi-occlusive application of sodium Molybdate to intact rabbit skin for four hours elicited no dermal irritation.

The overall irritation index after 4 days of observation was 0.0.Hence, sodium molybdate can be considered not irritating to skin.

Based on the available data for the target and read across substances and applying the weight of evidence approach, ammonium molybdate can be considered as not irritating to skin.Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified”.

Eye Irritation:

In different studies,Ammonium molybdatehas been investigated for potential for ocular irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits for target chemical and for the read across substance, sodium molybdate [CAS: 7631-95-0].

A study was conducted (NTRL submission report -OTS0000811, last updated 1991)to assess the irritation potential of ammonium molybdate. The study was performed according to OECD 405 Guidelines. 100 mg of 0.1 ml chemical was installed into thelower everted lid of 6 New Zealand White male rabbits. The contralateral eye remained untreated and served as a control. Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and.7 days after instillation. Observation of the eyes was aided by the use of a handheld torch. Grading and scoring of the ocular lesions were performed. One of the animals gave a "positive" response. No corneal damage or iridial inflammation was seen throughout the observation period. A diffuse crimson-red colouration of the conjunctivae was evident twenty-four hours after instillation only in one animal. Mild conjunctival inflammation was observed in the remaininq animals. All conjunctival reactions had resolved one to four days after instillation.

Instillation of Ammonium molybdate into the rabbit eyes elicited transient and very slight conjunctival inflammation only which were completely resolved after 4 days

The overall irritation scores after 7 days was 0.0

Based on the observations and scores, Ammonium molybdate can be considered not irritating to rabbit eyes.

This result is supported by the experimental study summarized in NTRL submission report -OTS0000811, last updated 1991; for the read across substance,sodium molybdate [CAS: 7631-95-0].The study was conducted as per OECD 405 Guidelines. 100 mg of 0.1 ml chemical was installed into thelower everted lid of 6 New Zealand White male and female rabbits. The contralateral eye remained untreated and served as a control. Examination of the eyes was made after 1 hour and 1, 2, 3, 4 and.7 days after instillation. Observation of the eyes was aided by the use of a handheld torch. Grading and scoring of the ocular lesions were performed.

One of the animals gave a "positive" response. No corneal damage or iridial inflammation was seen throughout the

observation period. A diffuse crimson-red colouration of the conjunctivae was evident twenty-four hours after instillation only in one animal. Mild conjunctival inflammation was observed in the remaininq animals. All conjunctival reactions had resolved one to four days after instillation.

Instillation of Sodium molybdate into the rabbit eyes elicited transient and very slight conjunctival inflammation only which were completely resolved after 4 days

The overall irritation scores after 7 days was 0.0

Based on the observations and scores, Sodium molybdate can be considered not irritating to rabbit eyes.

Based on the available data for the target and read across substances and applying the weight of evidence approach, ammonium molybdate can be considered as not irritating to eyes.Comparing the above annotations with the criteria of CLP regulation, test chemical can be classified under the category “Not Classified”

Justification for classification or non-classification

Available studies for ammonium molybdate suggests that it is not irritating to eyes and skin.

Hence,Ammonium molybdate can be classified under the category “Not Classified” as per CLP regulation.