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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Justification for type of information:
Data is from U.S. Environmental Protection Agency report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD 422 guideline (combined repeat dose study with a reproductive/developmental screen)
Principles of method if other than guideline:
Combined repeated dose repro-devp. Screen of Methylamine hydrochloride in rat
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Methylammonium chloride
EC Number:
209-795-0
EC Name:
Methylammonium chloride
Cas Number:
593-51-1
Molecular formula:
CH5N.ClH
IUPAC Name:
methanamine
Constituent 2
Reference substance name:
Methylamine hydrochloride
IUPAC Name:
Methylamine hydrochloride
Details on test material:
- Name of test material: Methylamine hydrochloride
- Molecular formula: - CH5N.ClH
Molecular weight: 67.5184 g/mol
- Smiles notation: C[NH3+].[ClH-]
- InChl: 1S/CH5N.ClH/c1-2;/h2H2,1H3;1H
- Substance type: Organic
Specific details on test material used for the study:
- Name of test material: Methylamine hydrochloride (MAH)
- IUPAC name: Methanaminium chloride
- Molecular formula: CH5NCl H
- Molecular weight: 67.5184 g/mole
- Substance type: Organic

Test animals

Species:
rat
Strain:
not specified
Details on test animals or test system and environmental conditions:
Sex: Male and female

Administration / exposure

Route of administration:
oral: gavage
Type of inhalation exposure (if applicable):
not specified
Vehicle:
water
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: Methylamine hydrochloride was dissolved in water to give a dose of 0, 250, 500 and 1000 mg/Kg bw

DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available

VEHICLE
- Justification for use and choice of vehicle (if other than water): Water
- Concentration in vehicle: 0, 250, 500, or 1000 mg/kg/day
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
- Length of cohabitation: 2 weeks
Duration of treatment / exposure:
Total:110
Premating period -71 days
Mating period-14 days
Gestation period-21 days
Postpartum day -4.
Frequency of treatment:
Daily
Duration of test:
110
Doses / concentrations
Remarks:
0, 250, 500 and 1000 mg/kg/day
No. of animals per sex per dose:
Total no of animals-96
0 mg/kg/day - 12 male and 12 female
250 mg/kg/day- 12 male and 12 female
500 mg/kg/day- 12 male and 12 female
1000 mg/kg/day- 12 male and 12 female
Control animals:
yes, concurrent vehicle
Details on study design:
No data available

Examinations

Maternal examinations:
Body weight and food consumption, gross pathology and histopathology was observed.
Ovaries and uterine content:
Implantation sites and ovarian corpora lutea also examined.
Fetal examinations:
Pup viability, individual pup weights, litter sizes.and clinical signs were observed at birth and on lactation day 4.
Statistics:
No data available
Indices:
Mean Number of Pups/Litter and Offspring viability indices was observed on day 0 and 4 of lactation were examined.
Historical control data:
No data available

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality:
not specified
Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
not specified
Details on results:
Body weight: Significant reductions in body weight in P1 animals were observed at 1000 mg/kg/day. Weight gain of pregnant females was less at 1000 mg /kg/day from gestational day 1 to day 7 (87.5% of control) but similar to the other groups at intervals after gestational day 7.

Food consumption: Significant reductions in food consumption were observed in P1 male and female rats.

Maternal developmental toxicity

Number of abortions:
not specified
Pre- and post-implantation loss:
effects observed, treatment-related
Total litter losses by resorption:
effects observed, treatment-related
Early or late resorptions:
not specified
Dead fetuses:
not specified
Changes in pregnancy duration:
not specified
Description (incidence and severity):
Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified
Changes in number of pregnant:
not specified
Other effects:
not specified
Details on maternal toxic effects:
Reproductive function: estrous cycle: Significant decrease in corpora lutea counts and subsequently lower implantation site counts and litter sizes were observed at 1000 mg/kg/day treated female rat.

Reproductive performance: No effect on Number of Pups/Litter were observed in treated female rats.

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
500 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
body weight and weight gain
food consumption and compound intake
pre and post implantation loss
other: No adverse effect

Results (fetuses)

Fetal body weight changes:
not specified
Description (incidence and severity):
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified
Reduction in number of live offspring:
no effects observed
Changes in sex ratio:
no effects observed
Changes in litter size and weights:
not specified
Changes in postnatal survival:
not specified
External malformations:
not specified
Skeletal malformations:
not specified
Visceral malformations:
not specified
Other effects:
not specified
Details on embryotoxic / teratogenic effects:
Viability: No effect on viability of treated pups were observed till day 4 of lactation as compared to control.

Effect levels (fetuses)

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No effect on Number of Pups/Litter and viability

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
no
Treatment related:
not specified
Relation to maternal toxicity:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified

Any other information on results incl. tables

MATBRNAL GROUP:

II-0

IV-0

 VI-0

VIII-0

DOSAGB{MG/KG/DAY):

0

250

500

1000

CORPORA LUTEA COUNTS

14.8

14.5

15.1

11.4*

Standard Deviation(No. in group)

2.3(12)

2.1(11)

1.8 (12)

3.3(10)

MEAN NUMBER OF PUPS/LITTER

 

 

 

 

Born

12.8

13.2

13.9

9.8

Born Alive

12.8

13.0

13.9

9.8

Day 4

12.8

12.0

13.9

9.7

Applicant's summary and conclusion

Conclusions:
NOAEL was considered to be 500 mg/kg bw/day for P1 generation and 1000 mg/kg bw/day for F1 generation when male and female rats were treated with Methylamine hydrochloride (Methanaminium chloride) orally by gavage for 110 days.
Executive summary:

In a repeated dose reproduction –development toxicity study, male and female rats were treated with Methylamine hydrochloride (Methanaminium chloride) in the concentration of0, 250, 500 and 1000 mg/kg/day orally by gavage in water. Test was conducted as per OECD 422. Significant decrease in body weight of P1 animals were observed at 1000 mg/kg/day. Weight gain of pregnant females was less at 1000 mg /kg/day from gestational day 1 to day 7 (87.5% of control) but similar to the other groups at intervals after gestational day 7. Significant reductions in food consumption were observed in P1 male and female rats. Similarly, significant decrease in corpora lutea counts and subsequently lower implantation site counts and litter sizes were observed at 1000 mg/kg/day treated female rat. But, No effect on Number of Pups/Litter were observed in treated female rats. In addition, No effect develpmental toxicity was observed in treated pups such as on viability till day 4 of lactation as compared to control at 250, 500 and 1000 mg/kg bw/day. Therefore, NOAEL was considered to be 500 mg/kg bw/day for P1 generation and 1000 mg/kg bw/day for F1 generation whenmale and female rats were treated withMethylaminehydrochloride (Methanaminium chloride) orally by gavage for 110 days.