Registration Dossier
Registration Dossier
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EC number: 800-766-3 | CAS number: 1424148-97-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study; well-performed and well-documented; the test material contained the registration substance by ca. 40%.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
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:
- sodium/triethanolamine- 6-(2,5-dioxo-3-C12-18-alkenyl(even and odd, branched, unsaturated)-pyrrolidin-1-yl)hexanoate
- EC Number:
- 800-766-3
- Cas Number:
- 1424148-97-9
- Molecular formula:
- C22H36NO4.1/2Na.1/2C6H16NO3 - C28H48NO4.1/2Na.1/2C6H16NO3
- IUPAC Name:
- sodium/triethanolamine- 6-(2,5-dioxo-3-C12-18-alkenyl(even and odd, branched, unsaturated)-pyrrolidin-1-yl)hexanoate
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- The test meterial contained the registration substanceby ca. 40%. The remaining components were teak oil, oleyl alcohol, polypropylen, and water.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- The test material contained the registration substance by ca. 40%. The other components are not considered to possess significant irritating potentials.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- three rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The skin irritation potential was investigated according to the OECD Guideline 404. The test material contained the registration substance by 40 %.
The outcome of the study corresponded to "irritating" for the test material according to DSD 67/548/EEC. Taking account that the corresponding acid is not an irritant toskin and no local effect was observed in the combined repeated dose and reproductive/developmental toxicity screening (OECD 422), the registraton substance is assessed to be of "irritating". Xi, R38 is assigned. - Executive summary:
The skin irritation potential was investigated according to the OECD Guideline 404. The test material contained the registration substance by 40 %.
The outcome of the study corresponds to "irritating" for the test material according to DSD 67/548/EEC, whereas further evidences were considered to be necessary due to applied dose concentration of 40%.
Further evidences included:
- The obtained potency is far from the borderline to "corrosive".
- The registration substance is salt of a weak acid. When dissolved in the biological fluid, an immediate dissociation is expected. The stable dissolved species are then sodim ion, triethanolammonium ion and acid form of the registration substance. The acid form of the registration substance is not skin irritating (data provided as supporting study) and no irritation can be assigned to sodium ion. Triethanolamine as well as triethanolammonium compounds (i.e. triethanolammonium chloride) are classified as "irritating" and not "corrosive".
- No local irritation effect was observed in the repeated dose toxicity study, in which the registration substance was given per gavage to the rats (endpoint study record provided in 7.5).
In conclusion, the assignment of "irritating" (R38 according to DSD 67/548/EEC) for the registration substance is justified.
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