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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
1st addendum to OECD 423, 22. March 1996
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-aminomethyl-2-methoxyphenol hydrochloride
EC Number:
230-468-3
EC Name:
4-aminomethyl-2-methoxyphenol hydrochloride
Cas Number:
7149-10-2
Molecular formula:
C8H11NO2.ClH
IUPAC Name:
4-aminomethyl-2-methoxyphenol hydrochloride
Test material form:
other: solid
Details on test material:
- Physical state: white solid
- Analytical purity: 99.77 %(w/w)
- Lot/batch No.: 77

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
three male and three female rats

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
with 1% carboxymethyl cellulose
Doses:
Single dose of 2000mg/kg bw
No. of animals per sex per dose:
three
Control animals:
no
Details on study design:
Animals were feeded ad libitum Altroin 1324 maintenance diet.
Animals were fasted prior to dosing over night and 3-4 hours after dosing.
Animals were observed for 14 days after dosing

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
no clinical signs of toxicity were observed
Body weight:
no weight loss was observed;
observed weight gain was within the expected range
Gross pathology:
Acute injection of blood vessels in all animals from euthanasia. No other macroscopic necropsy findings recorded.

Applicant's summary and conclusion

Interpretation of results:
other: "not classified" according CLP
Conclusions:
Vanillylamin hydrochloride did not show acute oral toxicity in Wistar rats at a dose level of 2000 mg/kg bw. Given these data the test item has no acute toxic characteristics.
Executive summary:

The test item Vanillylamin-HCl was given in a dose of 2000 mg/kg body weight to two groups of 3 male nad 3 female rats in a single exposure via oral gavage. A maximum dossage of 2000 mg/kg BW according to the acute tox class methiod regime, caued no compound related mortality within 14 days p. appl. No clinical signs of toxicity were observed throughout the observation period.