Registration Dossier
Registration Dossier
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EC number: 235-804-2 | CAS number: 12767-90-7
Endpoint summary
Administrative data
Description of key information
In vivo irritation studies on skin and eye irritation were performed on zinc borate (Kreuzmann, 1990; Daniels CL & Teske RH, 1969).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28/08/1990 - 28/09/1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Insecticide, Fungicide and Rodenticide Act 40 CFR
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Toxic Substances Control Act (40 CFR)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: King's Wheel Rabbitry.
- Age at study initiation: Young adult
- Weight at study initiation:
- Housing: Singly in wire mesh suspension cages.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least one day.
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 h dark/ 12 h light cycle. - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
VEHICLE
- Amount applied: Test substance was moistened with 0.5 mL physiological saline. - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3/sex
- Details on study design:
- TEST SITE
- Area of exposure:
- % coverage: Not specified; approxiamtely 1 inch.
- Type of wrap if used: gauze patch, two layers thick, held in place with adhesive tape. After application of the patch, the trunk of each rabbit was wrapped with rubber dental darn and secured with staples. An outer layer of gauze was wrapped around the trunk of each animal and secured with tape.
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed by a gentle sponging using a towel moistened with water or other appropriate solvent.
- Time after start of exposure: 4 h - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: Based on erythema and edema.
- Irritant / corrosive response data:
- No irritation persisted 72 hours following application. No changes in the colouration or texture of the skin were noted. No evidence of corrosion was found.
- Other effects:
- None noted
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The primary skin irritation was evaluated in compliance with the conditions specified in the regulation for the enforcement of the Federal Insecticide, Fungicide and Rodenticide Act, the TSCA and the OECD guidelines. No irritation persisted 72 h following application. The PII was found to be 0.2 on erythema and edema. No changes in colouration or texture of the skin were noted. No evidence of corrosion (necrosis) was found. The test material was classified as Toxicity Category IV (40 CFR 156) by dermal administration.
Reference
The Primary skin irritancy of XPI-187 Zinc Borate was evaluated in compliance with the conditions specified in the regulation for the enforcement of the Federal Insecticide, Fungicide and Rodenticide act, the Toxic Substances control act and the OECD guidelines.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28/08/1990 to 08/10/1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Insecticide, Fungicide and Rodenticide Act (40 CFR).
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: The Toxic Substances Control Act (40 CFR).
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline (not specified)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: King's Wheel Rabbitry
- Age at study initiation: Young adult
- Housing: Singly in wire mesh suspension cages.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: Animals were acclimated to the laboratory for at least one day prior to the test.
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 h dark/light cycle.
IN-LIFE DATES: From: 25/09/1990 To: 08/10/1990 - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye of each animal was used as a control.
- Amount / concentration applied:
- A dose of 0.083 g was applied.
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- Eyes were examined and graded for ocular reaction at approximately 1 h, 24 h, 48 h and 74 h after application. Except for the 1 h observation and only in corneal opacity scores of 2 or less are noted, the eyes will be scored again for corneal opacity intensity and area using fluorescein.
- Number of animals or in vitro replicates:
- Six (3 males, 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The eyes of the animals were rinsed.
- Time after start of exposure: 24 h
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: Fluorescein staining and ultra violet illumination. - Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Remarks:
- 6-929
- Time point:
- 72 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Remarks:
- 6-929
- Time point:
- 48 h
- Score:
- ca. 2
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Remarks:
- 6-929
- Time point:
- 24 h
- Score:
- ca. 3
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Remarks:
- 5-928
- Time point:
- 72 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Remarks:
- 5-928
- Time point:
- 48 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Remarks:
- 5-928
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Remarks:
- 4-927
- Time point:
- 72 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Remarks:
- 4-927
- Time point:
- 48 h
- Score:
- ca. 2
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Remarks:
- 4-927
- Time point:
- 24 h
- Score:
- ca. 3
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- 3-872
- Time point:
- 24/48/72 h
- Score:
- ca. 3
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 72 h
- Score:
- ca. 2
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 48 h
- Score:
- ca. 3
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- 1-870
- Time point:
- 24/48/72 h
- Score:
- ca. 2
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Remarks:
- 6-929
- Time point:
- 48 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Remarks:
- 6-929
- Time point:
- 24 h
- Score:
- ca. 2
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Remarks:
- 6-929
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Remarks:
- 6-929
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Remarks:
- 5-928
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Remarks:
- 5-928
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Remarks:
- 5-928
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Remarks:
- 4-927
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Remarks:
- 4-927
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Remarks:
- 4-927
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Remarks:
- 4-927
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- 3-872
- Time point:
- 72 h
- Score:
- ca. 3
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- 3-872
- Time point:
- 48 h
- Score:
- ca. 3
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- 3-872
- Time point:
- 24 h
- Score:
- ca. 4
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- 3-872
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- 3-872
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 48 h
- Score:
- ca. 2
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 24 h
- Score:
- ca. 3
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 24 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- 2-871
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- 1-870
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- 1-870
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- 1-870
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: Day4
- Score:
- 33
- Max. score:
- 110
- Reversibility:
- fully reversible
- Remarks on result:
- other: Maximum total irritation scores for individual animals ranged from 8 to 33.
- Irritant / corrosive response data:
- The test material produced corneal opacity which had cleared by Day 10, iritis that with some fluctuation ultimately cleared by Day 10 and conjunctival irritation which had cleared by Day 13. Maximum total irritation scores for individual animals ranged from 8 to 33.
No evidence of corrosion was noted. - Interpretation of results:
- Category II
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The primary ocular irritancy of XPI-187 zinc borate was evaluated in compliance with the conditions specified in the regulation for the enforcement of the Federal Insecticide, Fungicide and Rodenticide Act (40 CFR) the Toxic Substances Control Act (40 CFR) and the OECD guidelines.
The test material produced corneal opacity which had cleared by Day 10, iritis that with some fluctuation ultimately cleared by Day 10 and conjunctival irritation which had cleared by Day 13. Maximum total irritation scores for individual animals ranged from 8 to 33. No evidence of corrosion was noted. The test material was classified in Toxicity Category II (40 CFR 156, proposed) by ocular administration.
Reference
Primary eye irritation in rabbits following an ocular application of XPI-187 zinc borate:
Animal No.d | Reading | Corneaa | Iris | Conjunctivaa | Totalbc Score | |||
A | B | C | D | E | ||||
1-870 | 1 h | 0 | 0 | 0 | 2M | 1 | 2 | 10 |
24 h | 0/0 | 0/0 | 0 | 2N | 1 | 0 | 6/6 | |
48 h | 0/0 | 0/0 | 0 | 2M | 0 | 0 | 4/4 | |
72 h | 0/0 | 0/0 | 0 | 2M | 0 | 0 | 4/4 | |
Day 4 | 0/0 | 0/0 | 0 | 2 | 0 | 0 | 4/4 | |
Day 7 | 0/0 | 0/0 | 0 | 1 | 0 | 0 | 2/2 | |
Day 10 | 0/0 | 0/0 | 0 | 1 | 0 | 0 | 2/2 | |
Day 13 | 0/0 | 0/0 | 0 | 0 | 0 | 0 | 0/0 | |
2-871 | 1 h | 0 | 0 | 0 | 2W | 2 | 1 | 10 |
24 h | 1/1 | 0 | 1 | 2WGT | 3 | 2 | 24/24 | |
48 h | 1/1 | 1/1 | 0 | 3MT | 2 | 1 | 17/17 | |
72 h | 1/1 | 1/1 | 0 | 2T | 0 | 0 | 9/9 | |
Day 4 | 2/2 | 1/1 | 1 | 2T | 2 | 2 | 27 | |
Day 7 | 2/2 | 1/1 | 1 | 2 | 2 | 0 | 27 | |
Day 10 | 0/0 | 0/0 | - | 1 | 1 | 0 | 4/4 | |
Day 13 | 0/0 | 0/0 | 0 | 0 | 0 | 0 | 0/0 | |
3-872 | 1 h | 0 | 0 | 0 | 1WG | 1 | 1 | 6 |
24 h | 1/1 | 1/1 | 0 | 3WGP | 4 | 3 | 25/25 | |
48 h | 1/1 | 1/1 | 0 | 3T | 3 | 2 | 21/21 | |
72 h | 1/1 | 1/1 | 0 | 3T | 3 | 1 | 19/19 | |
Day 4 | 2/2 | 1/1 | 1 | 3 | 3 | 3 | 33/33 | |
Day 7 | 0/0 | 0/0 | 0 | 2 | 2 | 0 | 8/8 | |
Day 10 | 0/0 | 0/0 | 0 | 1 | 1 | 0 | 4/4 | |
Day 13 | 0/0 | 0/0 | 0 | 0 | 0 | 0 | 0/0 | |
4-927 | 1 h | 0 | 0 | 0 | 1WG | 2 | 3 | 12 |
24 h | 0/0 | 0/0 | 0 | 3W | 1 | 0 | 8/8 | |
48 h | 0/0 | 0/0 | 0 | 2M | 0 | 0 | 4/4 | |
72 h | 0/0 | 0/0 | 0 | 1 | 0 | 0 | 2/2 | |
Day 4 | 0/0 | 0/0 | 0 | 2MTR | 1 | 0 | 6/6 | |
Day 7 | 0/0 | 0/0 | 0 | 1 | 0 | 0 | 2/2 | |
Day 10 | 0/0 | 0/0 | 0 | 0 | 0 | 0 | 0/0 | |
5-928 | 1 h | 0 | 0 | 0 | 2WG | 0 | 2 | 6 |
24 h | 0/0 | 0/0 | 0 | 2W | 0 | 1 | 6/6 | |
48 h | 0/0 | 0/0 | 0 | 1 | 0 | 0 | 2/2 | |
72 h | 0/0 | 0/0 | 0 | 1 | 0 | 0 | 2/2 | |
Day 4 | 0/0 | 0/0 | 0 | 1T | 0 | 0 | 2/2 | |
Day 7 | 0/0 | 0/0 | 0 | 0T | 0 | 0 | 0/0 | |
6-929 | 1 h | 0/0 | 0/0 | 0 | 2WG | 2 | 2 | 12 |
24 h | 0/0 | 0/0 | 0 | 3WG | 2 | 2 | 14/14 | |
48 h | 0/0 | 0/0 | 0 | 2M | 1 | 0 | 6/6 | |
72 h | 0/0 | 0/0 | 0 | 1M | 0 | 0 | 2/2 | |
Day 4 | 0/0 | 0/0 | 0 | 1T | 0 | 0 | 2/2 | |
Day 7 |
|
|
| 0 | 0 | 0 | 0/0 | |
aA = degree of opacity; B = Area affected; C = erythema; D = swelling; E = discharge
bScoring key
ctotal score is the sum of the following three sub-totals, with a maximum score of 110; (/) = score without/with sodium fluorescein:
1. Degree of opacity x area involved x 5
2. Iris score x 5
3. (Sum of scores for erythema, swelling and discharge) x 2
dDue to the nature and the amount of the sample dosed, a small amount was lost on dosing each rabbit.
W = White sample-like material throughout the eye
M = viscous, white material in the lower lid of the eye
G = Blistered appearance to the conjunctiva
T = Thickened appearance to the conjunctiva
P = Eye gently pried open prior to scoring
R = At the time of scoring, upon manipulation of the eyelid, the lower conjunctiva exhibited a moderate amount of blood-like material exuding from the conjunctival tissue.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation
Zinc borate is not a skin irritant.
Eye irritation
Zinc borate anhydrous is an eye irritant.
Zinc borate heptahydrate is not an eye irritant.
See toxicokinetic section for read-across justification.
Justification for selection of skin irritation / corrosion endpoint:
Key study conducted with zinc borate anhydrous.
Justification for selection of eye irritation endpoint:
Key study conducted with zinc borate anhydrous.
Effects on eye irritation: irritating
Justification for classification or non-classification
Zinc borate was not classified for skin irritation under criteria defined in directive 67/548/EEC as no irritating effects were observed on application to the skin of test animals.
Zinc borate anhydrous is a Category 2 eye irritant based on reversible effects in eye irritation studies in test animals.
Zinc borate heptahydrate is not an eye irritation based on eye irritation studies in test animals.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
