Registration Dossier
Registration Dossier
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EC number: 947-794-3 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March to April 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-(1-{3,5-Bis[(dimethylamino)methyl]-4-hydroxyphenyl}-1-methylethyl)-2,6-bis[(dimethylamino)methyl]phenol
- Molecular formula:
- C27H44N4O2
- IUPAC Name:
- 4-(1-{3,5-Bis[(dimethylamino)methyl]-4-hydroxyphenyl}-1-methylethyl)-2,6-bis[(dimethylamino)methyl]phenol
- Reference substance name:
- 2,6-Bis[(dimethylamino)methyl]-4-(1-{3-[(dimethylamino)methyl]-4-hydroxyphenyl}- 1-methylethyl)phenol
- Molecular formula:
- C24H37N3O2
- IUPAC Name:
- 2,6-Bis[(dimethylamino)methyl]-4-(1-{3-[(dimethylamino)methyl]-4-hydroxyphenyl}- 1-methylethyl)phenol
- Reference substance name:
- 2-[(Dimethylamino)methyl]-4-(1-{3-[(dimethylamino)methyl]-4-hydroxyphenyl}-1-methylethyl)phenol
- Molecular formula:
- C21H30N2O2
- IUPAC Name:
- 2-[(Dimethylamino)methyl]-4-(1-{3-[(dimethylamino)methyl]-4-hydroxyphenyl}-1-methylethyl)phenol
- Reference substance name:
- Unknown impurities
- IUPAC Name:
- Unknown impurities
- Reference substance name:
- Xylene
- EC Number:
- 215-535-7
- EC Name:
- Xylene
- Cas Number:
- 1330-20-7
- Molecular formula:
- C8H10
- IUPAC Name:
- Benzene, dimethyl-
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Reference substance name:
- Sulphated ash
- IUPAC Name:
- Sulphated ash
- Test material form:
- solid: bulk
- Details on test material:
- - Name of test material (as cited in study report): HPP 12879-1
Constituent 1
Constituent 2
Constituent 3
impurity 1
impurity 2
impurity 3
impurity 4
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, dry
Test animals
- Species:
- rat
- Strain:
- other: CD / Crl: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks (males); approx. 9 weeks (females)
- Weight at study initiation: 252 - 270 g ( males); 224 - 251 g (females)
- Housing: During the 14-day observation period the animals were kept singly in MAKROLON cages (type III plus)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): no data available
- Photoperiod (hrs dark / hrs light): 12/1
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Statistics:
- none: limit test
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: At patch removal after exposition the epidermis under the test item was detached. The affected area was bloodless. Since test day 3 all lesions were covered with scab.
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- Necropsy revealed scarred application sites and/or application sites covered with scab.
Applicant's summary and conclusion
- Executive summary:
An acute dermal toxicity study was performed according to OECD TG 402. 2000 mg/kg of the test item was applied occlusive on 5 male and 5 female rats for 24 hours. No mortalities, no clinical signs, no effects on weight development were observed during the 14 -days observation period. At patch removal after exposition the epidermis under the test item was detached. The affected area was bloodless. Since test day 3 all lesions were covered with scab. Necropsy revealed scarred application sites and/or application sites covered with scab. The resulting LD50 was therefore > 2000 mg/kg bw for both sexes combined.
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