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Diss Factsheets

Administrative data

Description of key information

HMBDA is not irritating to skin and slightly irritating to the eye.

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
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Conventional Animal Breeding Unit
- Age at study initiation: Young adult
- Weight at study initiation: 3285-3684g
- Housing: Individual aluminium sheet cages (65.2 x 68.9 x 45.7 cm)
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-19°C
- Humidity (%): 30-70
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light):12/12
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500mg in approximately 0.5ml water
-Application site size: 2.5 x 2.5 cm
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5cm
- Type of wrap if used: surgical gauze secured by 2 crossed strips of surgical tape, covered with impermeable rubber sheeting secured with adhesive impermeable polyethylene tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): cleansed using cleam swabs of absorbent cotton wool soaked in clean warm water and gently dried with clean tissue paper
- Time after start of exposure: 4h

Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritant / corrosive response data:
Very slight erythema (grade 1) was observed in 2 animals, shortly after decontamination which had completely recovered after 24 hours. There were no other signs of irritation during the study.
Other effects:
None observed
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
HMBDA was not irritating to rabbit 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:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Conventional Animal Breeding Unit
- Age at study initiation: Young adults
- Weight at study initiation: 3649-3939g
- Housing: aluminium sheet cages (65.2 x 68.9 x 45.7 cm)
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-19°C
- Humidity (%): 30-70
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light):12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Approximately 100mg per eye
Duration of treatment / exposure:
Not applicable
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE:
Test substance was not removed

SCORING SYSTEM:
Draize 1959, Appendix C

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24/48/72 hours
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
There were no corneal or iridial effects. Conjunctival effects were only observed approximately 1 hour after application and consisted of slight redness in all 3 animals, slight chemosis in 1 animal, a slight discharge in 1 animal and severe discharge in 1 animal. Additional observations were confined to slight erythema on the upper and/or lower eyelid of 2 animals approximately 1 hour after application and a dried secretion on the periorbital skin of 2 animals 1 day after application. All signs of irritation had completely recovered by 24 hours.
Other effects:
Application into the eye caused a slight to moderate initial pain reaction (class 2-3 on a scale of 0-5).
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
HMBDA was a slight irritant to the rabbit eye
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

HMBDA is not irritating to skin and slightly irritating to the eye in reliable in vivo studies. These results were also supported by findings from additional, unreliable in vivo skin and eye irritation studies.


Justification for selection of skin irritation / corrosion endpoint:
Two skin irritation studies are available. The selected study has the higher Klimisch score.

Justification for selection of eye irritation endpoint:
Two eye irritation studies are available. The selected study has the higher Klimisch score.

Justification for classification or non-classification

HMBDA does not cause skin irritation and the degree of eye irritancy is insufficient to meet the classification criteria. Hence HMBDA is not classified for skin or eye irritancy.