Registration Dossier

Administrative data

Description of key information

Under the present conditions, test aritcle was considered to be no irritation to skin or eyes of animals.

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:
June 28 to July 1, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline test with GLP
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
ANIMAL MANAGEMENT
Three healthy adult rabbits of the New Zealand White strain were obtained from Froxfield (U.K.) Ltd., Petersfield, Hampshire, England.
They were in the weight range of 2.3 to 2.6 kg and approximately 10 to 12 weeks of age, prior to treatment @ay 1). All rabbits were acclimatised to the experimental environment.
The rabbits were selected without conscious bias for the study. They were housed individually in plastic cages with perforated floors in Building R 14 Room 1. A standard laboratory diet SDS Stanrab (P) Rabbit Diet and drinking water were provided ad libitum. The batch of diet used for the study was not analysed for nutrients, contaminants or micro-organisms. Results of routine chemical exarnination of drinking water at source as conducted usually weekly by the supplier, are made available to Huntingdon Research Centre Ltd. as quarterly sumrnaries.
Animal room temperature was maintained at approximately 19°C and relative humidity at 30 - 70%. These environmental Parameters were recorded daily. Air exchange was maintained at approximately 19 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.
Each animal was identified by a numbered aluminium tag placed through the edge of one ear. This number was unique within the HRC Industrial Toxicology Department throughout the duration of the study. Each cage was identified by a coloured labe1 displaying the study schedule number, animal number and initials of the Study Director and Home Office licensee.
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral skin
Amount / concentration applied:
Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 100 mm X 100 mm.
A 0.5 g amount of the test substance was applied under a 25 mm X 25 mm gauze pad which had been moistened with 0.5 ml distilled water to one intact skin site on each animal.
Each treatment site was covered with "Elastoplast" elastic adhesive dressing for four hours. The animals were not restrained during the exposure period and were returned to their cages immediately after treatment.
At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed with warm water (30" to 40°C) to remove any residual test substance. The treated area was blotted dry with absorbent Paper.
Duration of treatment / exposure:
4 hours
Observation period:
on Day 1 (i.e. approximately 60 minutes after removal of the dressings) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure).
Number of animals:
3
Details on study design:
Ciinical signs
All animals were observed daily for signs of ill health or toxicity.
Examination of the treated skin was made on Day 1 (i.e. approximately 60 minutes after removal of the dressings) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure).
Local dermal irritation was assessed using the prescribed numerical system:
Erythema 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) to slight eschar formation (injuries in depth)
preventing erythema reading 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 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending
beyond the area of exposure) 4
Any other lesion not covered by this scoring system, was described.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: Day 1 (i.e. approximately 60 minutes after removal of the dressings) and on Days 2, 3 and 4 (equivalent to 24, 48 and 72 hours after exposure).
Score:
0
Max. score:
8
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
8
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
8
Irritant / corrosive response data:
No dermal response to treatment was observed in any animal throughout the observation period.
Other effects:
There were no signs of toxicity or ill health in any rabbit during the observation period.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A single semi-occlusive application of test substance to intact rabbit skin for four hours revealed no dermal irritation and can therefore be considered to be non-irritant to rabbit's skin under the results described in this report.
Executive summary:

This study was performed to assess the skin irritation potential of test substance to the rabbit. The method followed was that described in OECD Guideline for Testing of Chemicals No. 404. Three rabbits were each administered a single dermal dose of 0.5 g of the test substance and observed for four days. No reactions were observed following a single semi-occlusive application of test substance to intact rabbit skin for four hours. Test article can therefore be considered to be non-irritant.

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:
June 30 to July 8, 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline test with GLP
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
ANIlMAL MANAGEMENT
Three healthy adult rabbits of the New Zealand White strain were obtained from Froxfield (U.K.) Ltd., Petersfield, Hampshire, England.
The animals were in the weight range of 2.2 to 3.3 kg and approximately 10 to 14 weeks of age, prior to treatment (Day 1). All rabbits were acclimatised to the experimental environment.
The rabbits were selected without conscious bias for the study. They were housed individually in plastic cages with perforated floors in Building R 14 Room 1.
A standard laboratory diet SDS Stanrab (P) Rabbit Diet and drinking water were provided ad libitum.
The batch of diet used for the study was not analysed for nutrients, contaminants or micro-organisms. Results of routine physical and chemical examination of drinking water at source as conducted usually weekly by the supplier, are made available to Huntingdon Research Centre Ltd. as quarterly sumrnaries.
Animal room temperature was maintained at approximately 19°C and relative humidity at 30 - 70%. These environmental Parameters were recorded daily. Air exchange was maintained at approximately 19 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.
Each animal was identified by a numbered aluminium tag placed through the edge of one ear. This number was unique within the HRC Industrial Toxicology Department throughout the duration of the study. Each cage, was identified by a coloured labe1 displaying the study schedule number, animal number and initials of the Study Director and Home Office licensee.
Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye remained untreated and used as control.
Amount / concentration applied:
Approximately 63 mg of the test substance, the weight occupying a volume of 0.1 ml, was placed into the lower everted lid of one eye of each animal.
Duration of treatment / exposure:
one second
Observation period (in vivo):
1h, 1, 2, 3, 4, 7 days after instillation
Number of animals or in vitro replicates:
3
Details on study design:
The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated.
Clinicai signs
All animals were observed daily for signs of ill health or toxicity.
Exarnination of the eyes was made after 1 hour and 1, 2, 3 (equivalent to 24, 48 and 72 hours after instillation), 4 and 7 days after instillation. Observation of the eyes was aided by the use of a handheld light.
Ocular irritation was assessed using the prescribed numerical System:
Cornea
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre),
details of iris clearly visible 1
Easily discernible translucent areas, 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 cornea involved
Zero 0
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, 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
Conjunctivae
Redness (refers to the most severe reading of palpebral and bulbar conjunctivae, as compared to the control eye)
Blood vessels normal : 0
Some blood vessels definitely hyperaemic (injected) : 1
Diffuse, crimson colour, individual vessels not easily discernible :2
Diffuse beeQ red : 3
Chemosis (iids andlor nictating 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
Any other lesion not covered by this scoring System, was described.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
8
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: one hour
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 4 day
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: day 4
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: day 2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: day 3
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 hour
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 1 day
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: day 3
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: day 3
Irritant / corrosive response data:
No corneai darnage or iridiai inflammation was observed.
A diffuse crimson colouration of the conjunctivae was seen in one animal one hour after instillation only .
Temporary mild conjunctival reactions only were Seen in the remaining animals.
The eyes were normal 3 or 4 days after instillation.
Other effects:
CLINICAL SIGNS
There were no signs of toxicity or ill health in any rabbit during the observation period.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Test article caused only mildly irritating to rabbit's eyes based on the results in this study.
Executive summary:

A study was performed to assess the eye irritation potential of BM1-resin to the rabbit. The method followed was that described in

OECD Guideline for Testing of Chemicais No. 405.

Three rabbits were each administered a single ocular dose of 63 mg of the test substance for one second and observed for seven days after instillation. A single instillation of test substance into the eye of the rabbit elicited transient mild conjunctivai irritation only. All reactions had resolved 3 or 4 days after instillation. Test substance can therefore be considered to be only mildly irritating. Test substance shall not be classified for eye irritation in accordance with CLP (Regulation EC No.1272/2008).

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

One available study(report no. OND 56c/940474/SE ) was performed to assess the skin irritation potential of test substance to the rabbit. The method followed was that described in OECD Guideline for Testing of Chemicals No. 404. Three rabbits were each administered a single dermal dose of 0.5 g of the test substance and observed for four days. No reactions were observed following a single semi-occlusive application of test substance to intact rabbit skin for four hours. Test article can therefore be considered to be non-irritant.

Eye irritation:

A study(report no. OND 57c/940477/SE ) was performed to assess the eye irritation potential of test article to the rabbit. The method followed was that described in

OECD Guideline for Testing of Chemicais No. 405.

Three rabbits were each administered a single ocular dose of 63 mg of the test substance for one second and observed for seven days after instillation. A single instillation of test substance into the eye of the rabbit elicited transient mild conjunctivai irritation only. All reactions had resolved 3 or 4 days after instillation. Test substance can therefore be considered to be only mildly irritating. Test substance shall not be classified for eye irritation in accordance with CLP (Regulation EC No.1272/2008).


Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the available data, test substance shall not be classified for eye/skin irritation in accordance with CLP (Regulation EC No.1272/2008).