Registration Dossier
Registration Dossier
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EC number: 246-905-6 | CAS number: 25371-55-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 20, 2004 - March 3, 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl hydrogen octadecylphosphonate
- EC Number:
- 246-905-6
- EC Name:
- Methyl hydrogen octadecylphosphonate
- Cas Number:
- 25371-55-5
- Molecular formula:
- C19H41O3P
- IUPAC Name:
- methoxy(octadecyl)phosphinic acid
- Reference substance name:
- Octadecylphosphonic acid
- EC Number:
- 225-216-4
- EC Name:
- Octadecylphosphonic acid
- Cas Number:
- 4724-47-4
- Molecular formula:
- C18H39O3P
- IUPAC Name:
- octadecylphosphonic acid
- Reference substance name:
- Dimethyl octadecylphosphonate
- EC Number:
- 246-904-0
- EC Name:
- Dimethyl octadecylphosphonate
- Cas Number:
- 25371-54-4
- Molecular formula:
- C20H43O3P
- IUPAC Name:
- dimethyl octadecylphosphonate
- Test material form:
- solid
Constituent 1
impurity 1
impurity 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Animals were held individually in suspended stainless steel cages. All housing and care were based on teh standards recommended by the Guide for the Care and Use of Laboratory Animals. Food and water was provided ad linitum to the animals throughout the study.Environmental Conditions:Room tempeature: 22°CRelative humidity: 47-63%Light cycle: 12-hour ligt/ 12-hour dark cycleRoom ventilation: 10-15 air changes/ hour
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 100% (unchanged)
- Duration of treatment / exposure:
- 3 minutes, 1-hour and 4-hours
- Observation period:
- 7 days
- Number of animals:
- 3 males
- Details on study design:
- On day -1, the animals chosen for use on the primary skin irrtiation study had the fur removed from the dorsal area of the trunk using animal clippers. The following day (day 0), the test article was applied to a small area of intact skin on each test animal for either 3 minutes, 1 hour or 4 hours. In all cases the test article was moistoned with 0.5mL of deionized water to form a paste and then administerd inder the gauze patch. The gauze was held in place with a non-irritating tape.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 3-Minute
- Score:
- 0.45
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 3 minute
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 0.11
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4 hour
- Score:
- 1.6
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4 hour
- Score:
- 0.22
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The 3-minute exposure to the test article produced slight erythem on 2/3 test sites at the 24 hour observation point. Dermal irritation resolved completley on 1/3 test sites by 48 hours and on the remaining site by the end of the 7 day observation period.The 1- hour exposure to the test article prodiuced well-defined erythema on 2/3 sites and slight oedema on 1/3 test sites by the 24-hour scoring interval. The dermal irritation resolved completely on both test sites by study day 7The 4-hour expoure to the test article produced very slight to well-defined erythem on 3/3 test sites and slight oedmea on 2/3 test sites by the 24-hour scoring interval. The dermal irritation resolved compleltley on all test sites by day 7.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Conclusions:
- Under the conditions of the test, MMOP did not produce evidence of corrosion during the 3 minute, 1-hour or 4-hour exposure periods.
- Executive summary:
The potential irritant and/or corrosive effects of MMOP were evaluated on teh skin of New Zealand White rabbits, Initially one animal was dosed. Since corrosivity was not observed in this animal, dosing was continued with two additional animals. Each rabbit received three 0.5 g of the test article as a single dermal application. The doses were held in contact with the skin undersemi occlusive conditions for an exposure time of three minutes, one hour and four hours, respectively.
The 3 minute exposure to the test article produced slight erythema on 2/3 test sites by the 24 -hour scoring interval. The dermal irritation resolved completely on 1/3 test sites bu the 48 -hour scoring interbal and on the remaining test site by study day 7.
1 -hour exposure to the test article produced well defined erythema on 2/3 test sites and slight edema on 1/3 test sites by the 24 -hour scoring interval. The dermal irritation resolved completley on both test sites by day 7.
4 -hour exposure to the test article produced very slight to well defind erythema on 3/3 test sites and slight oedema on 2/3 test sites by tehe 24 -hour scoring interval. The dermal irritation resolved completley on 3/3 test sites by study day 7.
Therefore, under the conditions of the test, MMOP did not produce evidence of corrosion during the 3 minute, 1 -hour or 4 -hour exposure period. It is a GHS Category 3 Mild Skin Irritant.
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