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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:
2016
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

Constituent 1
Chemical structure
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
Constituent 2
Chemical structure
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
Constituent 3
Chemical structure
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
impurity 1
Reference substance name:
Unknown impurities
IUPAC Name:
Unknown impurities
impurity 2
Chemical structure
Reference substance name:
Xylene
EC Number:
215-535-7
EC Name:
Xylene
Cas Number:
1330-20-7
Molecular formula:
C8H10
IUPAC Name:
Benzene, dimethyl-
impurity 3
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
water
impurity 4
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
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:
none
Body weight:
not influenced by treatment
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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