Registration Dossier
Registration Dossier
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EC number: 220-638-5 | CAS number: 2842-44-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-(N-methyl-p-toluidino)ethanol
- EC Number:
- 220-638-5
- EC Name:
- 2-(N-methyl-p-toluidino)ethanol
- Cas Number:
- 2842-44-6
- Molecular formula:
- C10H15NO
- IUPAC Name:
- 2-[methyl(4-methylphenyl)amino]ethan-1-ol
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three female New Zealand White rabbits, approximatcey 10 weeks of age, from Kuiper Rabbit Ranch were used in this study. The rabbits were recieved on October 13 1999 and random sample (33%) of the shipment weighed 2.09 to 2.33 kg the next day. The rabbits were held in quarantine for approximately 3 weeks during which time they were observed daily for survival and at the end of the quarantine period examined carefully to ensure their health and suitability as test subjects. Rabbits randomly selected for the study were identified by a uniquely numbered metal tag.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 ml of undiluted test substance
- Duration of treatment / exposure:
- 24 h, 72 h, 7 days and 14 days
- Observation period:
- 14 days
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24h/72h
- Score:
- 3.16
- Max. score:
- 8
- Reversibility:
- fully reversible within: 14 days
- Remarks:
- Scaly skin was observed in one rabbit at day 14
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritant / corrosive response data:
- Following exposure (e.g.; 30-60 minutes) to the test substance no edema was present in one rabbit while th other two rabbits range from very sligh to slight edema. Well defined to severe erythma was observed in all rabbits at the 30- 60 minute scoring interval. Very sligt to slight edema was observed at the 24-hour scoring interval and persisted in one rabbit as very slight edema through 72 hours. Very slight to severe erythema was observed at the 24 hours scoring interval and persisted in all rabbits through 72 hours. One rabbit exhibited eschar formation at 24 hours through 7 days following exposure. Scarly skin was observed in one rabbit at 14 days, otherwise all rabbits completly recovered from signs of dermal irritation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No signs of dermal corrosivity were observed at any time during the study. The Primary Dermal Irritation Score for MHPT was 3.16.
- Executive summary:
MHPT was applied undiluted for 4 hours to the shaved backs of three New Zealand White rabbits at a dose of 0.5 ml. Residual test substance was removed with the aid of propylene glycol. All test sites were examined for signs of dermal irritation (i.e. edema, erythema and/or echar formation) and corrosivity at 30-60 minutes, 24, 48 and 72 hours and 7 and 14 days following removal of the wrappings.
No signs of dermal corrosivity were observed at any time during the study. The Primary Dermal Irritation Score for MHPT was 3.16.
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