Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

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:
January 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Purity: 97.27%
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
All animals were housed singly in stainless steel, wire-mesh cages suspended above cage boards.
Animal rooms were maintained at a temperature of 16-22°C and a relative humidity of 30-70%.
Animal rooms were artificially illuminated (fluorescent light) on an approximate 12-hour light/dark cycle.
The rabbits were offered approximately 125 grams of PMI® Nutrition International, LLC Certified Rabbit LabDiet® 5322 daily during the study. Water was available ad libitum.
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
deionized
Controls:
no
Amount / concentration applied:
0.5 g of bromacil, moistened with 0.4 mL of deionized water to form a thick paste
Duration of treatment / exposure:
4 h
Observation period:
60 minutes after removal of the test patches, the test sites were evaluated.
Additional evaluations were made at approximately 24, 48, and 72 hours after removal of the patches.
Number of animals:
3 female rabbits
Details on study design:
Area of exposure: approximately 6 cm²
Test site was covered with a 2-ply gauze pad
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Interpretation of results:
GHS criteria not met
Conclusions:
The objective of this study was to evaluate the skin irritation/corrosive potential and the reversibility of dermal effects of bromacil following a 4-hour dermal exposure in albino rabbits.
The rabbits exhibited no dermal irritation during the study. No clinical signs of toxicity were observed, and no body weight loss occurred.
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:
January 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Purity: 97.27 %
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
All animals were housed singly in stainless steel, wire-mesh cages suspended above cage boards.
Animal rooms were maintained at a temperature of 16-22°C and a relative humidity of 30-70%.
Animal rooms were artificially illuminated (fluorescent light) on an approximate 12-hour light/dark cycle.
The rabbits were offered approximately 125 grams of PMI® Nutrition International, LLC Certified Rabbit LabDiet® 5322 daily during the study. Water was available ad libitum.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.09 g of bromacil was introduced into the lower conjunctival sac of the right eye
Duration of treatment / exposure:
The treated and control eyes of all rabbits remained unwashed. 72 h of exposure
Observation period (in vivo):
Approximately 1, 24, 48, and 72 hours after bromacil was administered, the rabbits were examined
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
The eyes were examined using illumination and magnification and scored for ocular reactions according to the Draize Scale
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
other: cornea area
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Irritation parameter:
other: cornea area
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Irritation parameter:
other: cornea area
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Irritation parameter:
other: cornea area
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
other: cornea area
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
other: cornea area
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1 h
Score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1 h
Score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48 h
Score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48 h
Score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 h
Score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1 h
Score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
48 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #2
Time point:
other: 1 h
Score:
3
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #3
Time point:
other: 1 h
Score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #3
Time point:
24/48 h
Score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
animal #3
Time point:
72 h
Score:
0
Interpretation of results:
GHS criteria not met
Conclusions:
Bromacil was evaluated for acute eye irritation potential in 3 young adult New Zealand White rabbits. A skin irritation study was previously conducted. The test substance was not a severe skin irritant or corrosive to the skin. The classification is not required based on the results and according to regulation (EC) No 1272/2008 (CLP regulation).
Executive summary:

Iritis (score of 1) was observed in the treated eye of 2 rabbits, conjunctival redness (score of 1 or 2) was observed in the treated eye of three rabbits, conjunctival chemosis (score of 1, 2, or 3) was observed in the treated eye of two rabbits, and discharge (score of 2 or 3) was observed in the treated eye of two rabbits. Irritation resolved in the rabbits by 24 or 72 hours after instillation of the test substance. Fluorescein stain examinations were negative for corneal injury in the treated eye of all rabbits. No clinical signs of toxicity were observed and no biologically important body weight loss occurred.

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

Additional information

Justification for classification or non-classification

The skin irritation/corrosive potential and the reversibility of dermal effects of bromacil following a 4-hour dermal exposure in albino rabbits was evaluated. The rabbits exhibited no dermal irritation during the study. No clinical signs of toxicity were observed, and no body weight loss occurred.

Bromacil was also evaluated for acute eye irritation potential in 3 young adult New Zealand White rabbits. The test substance was not a severe skin irritant or corrosive to the skin. The classification is not required based on the results and according to regulation (EC) No 1272/2008 (CLP regulation).