Registration Dossier
Registration Dossier
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EC number: 700-990-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29/06/1981 - 08/09/1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP study according to EPA Guideline (Fed. Reg. 43:163, 37336-37402, 1978). QA. Diet and environmental conditions not reported. Acceptable basic data.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Guideline for registering Pesticides in the U.S.; Hazard Evaluation: Humans and Domestic Animals, Fed. Reg. 43:163, 37336-37402, 1978.
- Deviations:
- yes
- Remarks:
- Exposure time: 24 hours
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-tert-butylphenyl diphenyl phosphate; bis(4-tert-butylphenyl) phenyl phosphate; triphenyl phosphate
- EC Number:
- 700-990-0
- Cas Number:
- 68937-40-6
- Molecular formula:
- vary
- IUPAC Name:
- 4-tert-butylphenyl diphenyl phosphate; bis(4-tert-butylphenyl) phenyl phosphate; triphenyl phosphate
- Details on test material:
- - Name of test material (as cited in study report): tertbutylphenyl diphenyl phosphate
- Physical state: liquid
- Sample description: Butylated Arylphosphate - 10141D0404
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Stauffland albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Phillips Rabbitry, Soquel, California, USA
ENVIRONMENTAL CONDITIONS: No data
IN-LIFE DATES: No data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted (100%) - Duration of treatment / exposure:
- 24 hours
- Observation period:
- After 24 and 72 hours of exposure
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: No data
- % coverage: No data ( one-inch square gauze patch)
- Type of wrap if used: The patches were secured in place by adhesive tape and wrapped with rubberized damming for the 24-hour period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: Removal after 24 hours
SCORING SYSTEM: The scoring criteria as described by Draize (Draize, J. H. (1965). Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics - Dermal Toxicity, Assoc. of Food and Drug Officials of the U.S. Topeka, Kansas, pp. 49-52). Erythema and Eschar formation / Oedema formation. Primary Irritation Index scores.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- intact and abraded skin
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: no 14 days observation period done for reversibility
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Intact and abraded skin
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Intact and abraded skin
- Time point:
- 24 h
- Score:
- 0.5
- Max. score:
- 0.5
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- intact and abraded skin
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- intact and abraded skin
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- intact and abraded skin
- Time point:
- 24 h
- Score:
- 0.25
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- intact and abraded skin
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other:
- Remarks:
- no 14 days observation period done for reversibility
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- intact and abraded skin
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- intact and abraded skin
- Time point:
- 72 h
- Score:
- 0.5
- Max. score:
- 0
- Reversibility:
- fully reversible within: 72hours
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- intact and abraded skin
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- intact and abraded skin
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- intact and abraded skin
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72hours
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 72hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- other: No measurements after 48 hours
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- No measurments after 48 hours
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Phosflex 72B produced mild erythema (4 rabbits) and mild edema (1 rabbit) in intact and abraded skin of albino rabbits following a 24 hour exposure. At the 72 hour observation, irritation decreased and included mild erythema in one of the six rabbits (no 14 days observation period done for reversibility).
- Other effects:
- None
Any other information on results incl. tables
Primary Irritant Score = 0.46
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Phosflex 72B produced mild erythema (4 rabbits) and mild edema (1 rabbit) in intact and abraded skin of albino rabbits following a 24 hour exposure. At the 72 hour observation, irritation decreased and included mild erythema in one of the six rabbits (no 14 days observation period done for reversibility). Based on these results and according to the EU criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS), Phosflex 72B does not have to be classified and has no obligatory labelling requirement for skin irritation.
- Executive summary:
The primary irritation of the skin was measured by a patch-test technique on the abraded and intact skin of six Stauffland albino rabbits, according to EPA Guideline Fed. Reg. 43:163, 37336-37402, 1978. 0.5 ml of the test substance (Phosflex 72B) was introduced under a one-inch square gauze patch. The patches were secured in place by adhesive tape and wrapped with rubberized damming for a 24 hour period. After 24 hours of exposure, the patches and test material were removed, and the resulting reactions were given a score. Readings were made after 24 and 72 hours, and the final score represents an average of all readings. The scoring and evaluation criteria are those described by Draize (1965).
Phosflex 72B produced mild erythema (4 rabbits) and mild edema (1 rabbit) in intact and abraded skin of albino rabbits following a 24 hour exposure. At the 72 hour observation, irritation decreased and included mild erythema in one of the six rabbits (no 14 days observation period done for reversibility). Based on these results and according to the EU criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS), Phosflex 72B does not have to be classified and has no obligatory labelling requirement for skin irritation.
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.
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