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Administrative data

Description of key information

An acute eye irritation/corrosion and a primary skin irritation/corrosion study was performed with F-2200HM in the rabbit (4 -hour semi-occlusive application). F-2200HM was not classified as irritating. 

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
Study period:
29/06/1999-02/07/1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP comparable to OECD guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Principles of method if other than guideline:
/
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Nederland, The Netherlands
- Age at study initiation:at least 6 weeks
- Weight at study initiation:less than 3.5kg
- Housing:Individually housed in labelled cages with perforated floors (Scanbur Denmark) and equipped with an automatic drinking system.
- Diet (e.g. ad libitum): approx. 100g per day
- Water (e.g. ad libitum):ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C):21°C
- Humidity (%):50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12 hours artificial fluorescent light, 12 hours dark

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g

Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure:150cm²
- Type of wrap if used: a Metallin patch (2x3 cm) was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic badage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: four hours

SCORING SYSTEM:
EYRTHEMA AND ESCHAR FORMATION:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness):4

OEDEMA FORMATION:
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well defined by definite raising): 2
Moderate oedema (raised approximately 1mm): 3
Severe oedema (raised more than 1mm and extending beyond area of exposure): 4
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Time point:
other: 1 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: 1h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
no skin irritation was caused by 4 hours of exposure to F-2200HM
Other effects:
no other effects were reported
Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commision Directive 93/21/EEC). F-2200HM does not have to be classified and has no obligatory labelling requirement for skin irritation.
Executive summary:

Primary skin irritation/corrosion study with F-2200HM in the rabbit (4 -hour semi-occlusive application).

The study was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, B.4: 'Acute Toxicity. Skin irritation' and OECD No. 404, 'Acute Dermal Irritation/Corrosion'.

Three rabbits were exposed to 0.5 gram of F-2200HM, applied onto clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure.

No skin irriation was caused by 4 hours of exposure to F-2200HM.

Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), F-2200HM does not have to be classified and has no obligatory labelling requirement for skin irritation.

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:
05/07/1999-08/07/1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP comparable to OECD guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
/
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Nederland, The Netherlands
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: less than 3.5 kg
- Housing: Individually housed in labelled cages with perforated floors (Scanbur, Denmark) and equipped with an automatic drinking system
- Diet (e.g. ad libitum): approx. 100g per day
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):21°C
- Humidity (%): 50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12hours artificial fluorescent light and 12 hours dark

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100mg (99.5-100.5mg)

Duration of treatment / exposure:
24 hours
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): 2% fluorescein in water (adjusted to pH7)
- Time after start of exposure: 24hours

SCORING SYSTEM:
Corneal irritation:
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity (may include slight dulling of normal lustre): 0
Scattered or diffuse areas of opacity, details of iris clearly visible: 1
Easily discernible translucent area, details or iris slightly obscured: 2
Necreous aera, no details of iris visible, size of pupil barely discernible: 3
Opaque cornea, iris not discernible throught the opacity: 4

Area of cornea involved:
No ulceration or opacity: 0
One quarter or less but not zer: 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 deopened rugae, congestion, swelling, moderate circumcorneal hyperaomia, or injection, any of these combination thereof, iris still reacting to light (slugggish reaction is possitive): 1
No reaction to light, hemmorrhage, gross destruction (any or all of these): 2

Conunctival irritation:
Redness (refers to palpebrae and sclera, excluding cornea and iris):
Blood vessels normal: 0
Some blood vessels definitely hyperaemic (injected): 1
Diffuse, crimson color, individual vessels not easily discernable: 2
Diffuse beefy red: 3

Chemosis (refers to lids and/or nictitating membranes):
No swelling: 0
Any swelling above normal (includes nictating membranes): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids more than half closed: 4
Discharge: No discharge (may include small amounts observed in inner canthus of normal animals): 0
Any amount different from normal and/or lacrimation: 1
Discharge with moistening of the lids and hairs just adjecent to lids: 2
Discharge with moistening of the lids and hairs (considerable area around the eye): 3

TOOL USED TO ASSESS SCORE: fluorescein + an ophthalmic examination lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
0.33
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
0.67
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 1hour
Score:
2
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24 hours
Score:
1.67
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 48hours
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 72hours
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
1.67
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24hours
Score:
1.5
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48hours
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72hours
Score:
0
Max. score:
4
Irritation parameter:
other: Discharge
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
3
Irritation parameter:
other: Discharge
Basis:
mean
Time point:
other: 24hours
Score:
0.33
Max. score:
4
Irritation parameter:
other: Discharge
Basis:
mean
Time point:
other: 48hours
Score:
0
Max. score:
4
Irritation parameter:
other: Discharge
Basis:
mean
Time point:
other: 72hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
Corneal injury was seen in one animal as opacity (fmax. grade 1) and epithelial damage (max. 25% of the corneal area). The corneal injury had resolved within 72 hours?
Irridial irritation (grade 1) was observed in two animals after 1 hour only. Irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 72 hours in all animals.
Other effects:
Colouration: remnants of the test substance were present in the eyes of all animals on day 1.
Interpretation of results:
GHS criteria not met
Conclusions:
Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commision Directive 93/21/EEC), F-2200HM does not have to be classified and has no obligatory labelling requirement for eye irritation.
Executive summary:

Acute eye irritation/corrosion study with F-2200HM in the rabbit.

The study was carried out based on the guideline described in: EC Commission Directive 92/69/EEC, B., Acute Toxicity. Eye irritation and OECD No. 405, 'Acute Eye Irritation/Corrosion'.

Single samples of approximately 100mg of F-2200HM (a volume of approximately 0.1ml) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation.

Instillation of the test substance resulted in effects on the cornea, iris and conjunctivae.

Corneal injury was seen in one animal as opacity (max grade 1) and epithelial damage (max. 25% of the corneal area). The corneal injury had resolved within 72 hours.

Irridial irritation (grade 1) was observed in two animals after 1 hour only. Irritation of the conjunctivae was seen as redness. Chemosis and discharge which had completely resolved within 72 hours in all animals.

Remnants of the test substance were present in the eyes of all animals on day 1.

Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC). F-2200HM does not have to be classified and has no obligatory labelling requirement for eye irritation.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Only one study available

Justification for selection of eye irritation endpoint:
Only one study available

Justification for classification or non-classification

Not classified according to the Commision directive 93/21/EEC.