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Administrative data

Description of key information

Skin irritation: performed according to standard method, rabbits: slightly irritating but no classification is required (Pasquet, 1976).

Eye irritation: performed according to standard method, rabbits: slightly irritating but no classification is required (Pasquet, 1976). 

Respiratory irritation: No data available.

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:
(no data on starting date) 30-AUG 1976 (date of report)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted before GLP principles (1976). However, study performed according to basic scientific principles acceptable for assessment although some information is missing on test conditions and on tes substance composition.
Qualifier:
according to guideline
Guideline:
other: performed according to standard method
Deviations:
not applicable
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data available
- Age at study initiation: no data available
- Weight at study initiation: no data available
- Housing: no data available
- Diet (e.g. ad libitum): no data available
- Water (e.g. ad libitum): no data available
- Acclimation period: no data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data available
- Humidity (%): no data available
- Air changes (per hr): no data available
- Photoperiod (hrs dark / hrs light): no data available

IN-LIFE DATES: From: To: no data available
Type of coverage:
not specified
Preparation of test site:
other: intact skin and abraded skin
Vehicle:
other: vaseline oil
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Concentration: 100% (as such) and 30% (diluted product in vaseline oil)

VEHICLE
Vaseline oil. No other information available.

NEGATIVE CONTROL
No data available

POSITIVE CONTROL
No data available
Duration of treatment / exposure:
no data available
Observation period:
3 days
Number of animals:
6 for each concentration
Details on study design:
TEST SITE
- Area of exposure: no data available. The product has been applied on the intact and abraded skin.
- % coverage: no data available
- Type of wrap if used: no data available

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data available
- Time after start of exposure: no data available

OBSERVATION TIME POINTS
24 and 72 hours

SCORING SYSTEM:
- Method of calculation: no data available
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.66
Reversibility:
not specified
Remarks on result:
other: Intact skin / product as such (concentration: 100%)
Remarks:
48h: not determined
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
other: not applicable
Remarks on result:
other: intact skin / product as such (concentration: 100%)
Remarks:
48h: not determined
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.25
Reversibility:
not specified
Remarks on result:
other: abraded skin / product as such (concentration: 100%)
Remarks:
48h not determined
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.66
Reversibility:
fully reversible
Remarks on result:
other: abraded skin / product as such (concentration: 100%)
Remarks:
48h not determined
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
1.29
Max. score:
8
Reversibility:
not specified
Remarks on result:
other: 48h not determined
Irritant / corrosive response data:
Based on this score, the substance is slightly irritating to rabbit's skin.

No detail is given to the concentration of 30%, since no signs of irritation were noted.

Table 1: local skin tolerance in rabbits - 100% concentration (product as such)

 

Observation after :

Rabbit

Intact skin

Abraded skin

Erythema

Edema

Erythema

Edema

24 hours

1

2

3

4

5

6

1

1

0

1

2

1

0

0

0

0

0

0

2

2

2

2

2

2

2

1

1

1

2

1

72 hours

1

2

3

4

5

6

0

1

0

0

1

0

0

0

0

0

0

0

1

1

0

0

1

0

0

0

0

0

0

0

Interpretation of results:
GHS criteria not met
Conclusions:
According to the Un GHS and CLP criteria, the substance is not classified for the skin irritation.
Executive summary:

Rhodiantal IBCH (100% (as such) and 30% (diluted product in vaseline oil) has been applied to the intact and abraded skin of six rabbits.

Period of observation: 24 and 72 hours. No more information is available.

Results: For the concentration of 100%, the mean scores (24 and 72h) were 0.66 for erythema and 0 for edema on the intact skin . Based on this score the substance is slightly irritating to rabbit’s skin.

According to the UN GHS and CLP criteria, the substance is not classified for the skin irritation.

For the concentration 30%, no signs of irritation were noted.

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:
(no data on starting date) 30-AUG 1976 (date of report)
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted before GLP principles (1976). However, study performed according to basic scientific principles acceptable for assessment although some information is missing on test conditions and on test substance composition.
Qualifier:
according to guideline
Guideline:
other: performed according to standard method
Deviations:
not applicable
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data available
- Age at study initiation: no data available
- Weight at study initiation: no data available
- Housing: no data available
- Diet (e.g. ad libitum): no data available
- Water (e.g. ad libitum): no data available
- Acclimation period: no data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data available
- Humidity (%): no data available
- Air changes (per hr): no data available
- Photoperiod (hrs dark / hrs light): no data available

IN-LIFE DATES: From: To: no data available
Vehicle:
other: vaseline oil
Amount / concentration applied:
TEST MATERIAL
- Concentration: 100% (as such), 10% and 30% (diluted product in vaseline oil)

VEHICLE
Vaseline oil. No other information available.

Duration of treatment / exposure:
no data available
Observation period (in vivo):
1 hour, 1, 2, 3, 4 and 7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data available
- Time after start of exposure: no data available

SCORING SYSTEM:
Conjunctival lesions and discharge
Chemosis (lids and/or nictitating membranes)
- no swelling . 0
- any swelling above normal (includes nictitating 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
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
- blood vessels normal ...................................................................................................................................................0
- a number of blood vessels definitely hyperemic (injected) .........................................................................................1
- diffuse, crimson colour, individual vessels not easily discernible ...............................................................................2
- diffuse, beefy red ........................................................................................................................................................3
Discharge
- absence of discharge ..................................................................................................................................................0
- slight discharge (does not include small amounts normally found in inner canthus) ...................................................1
- discharge with moistening of lids and hairs adjacent to lids ................................................................................ .......2
- discharge with moistening of lids and hairs on wide area around the eye .......................................................... ......3

Iris lesions
- normal ............................................................................................................................................................................0
- markedly deepened rugae, congestion, swelling, moderate circum-corneal hyperemia, or injection,
any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) ..............................1
- no reaction to light, haemorrhage, gross destruction (any or all of these)....................................................................2

Corneal lesions
Degree of opacity (area most dense taken for reading)
- no ulceration or opacity ................................................................................................................................................0
- scattered or diffuse areas of opacity (other than slight dulling or normal lustre), details of iris clearly visible ...........1
- easily discernible translucent area, details of iris slightly obscured ............................................................................2
- nacreous areas, no details of iris visible, size of pupil barely discernible ...................................................................3
- opaque cornea, iris not discernible through the opacity ...............................................................................................4
Area of opacity
- one quarter (or less) but not zero .................................................................................................................................1
- greater than one quarter but less than a half ................................................................................................................2
- greater than one half but less than three quarters ........................................................................................................3
- greater than three quarters up to whole area ................................................................................................................4

TOOL USED TO ASSESS SCORE: no data available

Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0.22
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: concentration 100%
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.38
Max. score:
2
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: concentration 100%
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
24/48/72 h
Score:
0.44
Max. score:
3
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: concentration 100%
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0.05
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: concentration 100%
Irritant / corrosive response data:
Based on this score, the substance is sightly irritating for eyes in rabbit.
No details are given for the concentration of 10%, since no signs of irritation were noted.
For the concentration 30%, see details in table n°2. For the concentration 30%, the substance is very slightly irritating for eyes in rabbit. Irritant effects (scores 1) were observed at 24 hours and fully reversible within: 48 hours.
Other effects:
none

Table n°1: Local ocular tolerance in rabbits - 100% concentration (product as such)

Observations after :

Rabbits

Conjunctivae

Iris

Corneal opacity

Discharge

Chemosis

Redness

Intensity

Area

1 hour

1

2

3

4

5

6

0

0

0

0

0

0

0

0

0

0

0

0

1

1

1

1

1

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1 day

1

2

3

4

5

6

0

1

0

2

0

0

0

0

0

0

1

0

1

1

1

1

1

1

1

0

1

1

1

1

0

0

0

1

1

1

0

0

0

4

2

2

2 days

1

2

3

4

5

6

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

0

0

0

0

0

1

0

0

0

0

0

1

0

0

0

0

0

4

0

3 days

1

2

3

4

5

6

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1

0

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

4 and 7 days

1

2

3

4

5

6

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Table n°2: Local ocular tolerance in rabbits -30% concentration (in vaseline oil)

Observations after :

Rabbits

Conjunctivae

Iris

Corneal opacity

Discharge

Chemosis

Redness

Intensity

Area

1 hour

1

2

3

4

5

6

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1 day

1

2

3

4

5

6

0

0

1

0

1

0

0

0

0

0

0

0

1

1

1

1

1

1

1

1

1

1

1

1

0

0

0

0

0

0

0

0

0

0

0

0

2, 3, 4 and 7 days

1

2

3

4

5

6

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Interpretation of results:
GHS criteria not met
Conclusions:
According to the UN GHS and CLP criteria, the substance is not classified for the eye irritation.
Executive summary:

Rhodiantal IBCH (100% (as such), 30% and 10% (diluted product in vaseline oil) has been instilled in eye rabbits. Period of observation: 7 days. No more information is available.

Results: For the concentration 100%, mean scores (24, 48 and 72h) were 0.05 for chemosis, 0.44 for conjunctival redness, 0.38 for iritis and 0.22 for corneal opacity. Based on this score the substance is slightly irritating for eyes in rabbit. According to the GHS and CLP criteria, the substance is not classified for the eye irritation. For the concentration 30%, the substance is very slightly irritating for eyes in rabbit. Irritant effects (scores 1) were observed at 24 hours and fully reversible within: 48 hours.

For the concentration 10%, no signs of irritation were noted.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion:

One Klimisch score 2 study was available for dermal irritation and was used as a key study. In this study (1976), Rhodiantal IBCH (100% (as such) and 30% (diluted product in vaseline oil) has been applied to the intact and abraded skin of six rabbits. Period of observation: 24 and 72 hours. No more information is available. For the concentration of 100%, the mean scores (24 and 72h) were 0.66 for erythema and 0 for edema on the intact skin. Based on this score the substance is slightly irritating to rabbit’s skin. According to the UN GHS and CLP criteria, the substance is not classified for the skin irritation.

Eye irritation:

One Klimisch score 2 study was available for dermal irritation and was used as a key study. In this study (1976), Rhodiantal IBCH (100% (as such), 30% and 10% (diluted product in vaseline oil) has been instilled in eye rabbits. Period of observation: 7 days. No more information is available.

For the concentration 100%, mean scores (24, 48 and 72h) were 0.05 for chemosis, 0.44 for conjunctival redness, 0.38 for iritis and 0.22 for corneal opacity. Based on this score the substance is slightly irritating for eyes in rabbit. According to the GHS and CLP criteria, the substance is not classified for the eye irritation.

Justification for classification or non-classification

Harmonized classification:

No harmonized classification is available according to the Regulation (EC) No 1272/2008.

 

Self classification:

Phenol, 2-methoxy-, reaction products with 2,2- dimethyl-3-methylenebicyclo[2.2.1]heptane, hydrogenated is not classified for skin and eye irritation according to the Regulation (EC) 1272/2008 (CLP) and to the Directive 67/548/EEC.

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