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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
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.