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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

developmental toxicity
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data from handbook or collection of Data (peer reviewed, OECD SIDS)

Data source

Reference Type:
secondary source
Salicylate intoxication and congenital anomalies.
Goldman, A.S. and Yakovac, W.C.
Bibliographic source:
Arch. Environ. Health. 8, 648-656 (1964), cited in: OECD SIDS Ammonium Chloride, Final 8/2006

Materials and methods

Principles of method if other than guideline:
The test substance is administered as a single dose to a group of 10 pregnant experimental Sprague Dawley rats for 4 days of pregnancy (from day 7-10) covering part of the period of organogenesis. Shortly before the expected date of delivery, the mother is sacrificed, the uterus removed, and the contents examined for embryonic or foetal deaths, and live foetuses.
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium chloride
EC Number:
EC Name:
Ammonium chloride
Cas Number:
Molecular formula:
ammonium chloride
Details on test material:
- Name of test material (as cited in study report): Ammonium chloride
- Analytical purity: no data

Test animals

Details on test animals or test system and environmental conditions:


Administration / exposure

Route of administration:
oral: drinking water
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
no data
Duration of treatment / exposure:
day 7 - 10 of gestation (4 days)
Frequency of treatment:
once a day
Duration of test:
20 days
Doses / concentrations
Dose / conc.:
8.9 mg/kg bw/day
1/6M, 1 ml/kg b.w. (equivalent to 8.9 mg/kg bw/day)
No. of animals per sex per dose:
10 female animals
Control animals:
yes, concurrent vehicle


Maternal examinations:
Maternal death was inspected.
Fetal examinations:
The foetuses were examined grossly after delivery by cesarean section on day 20. Resorptions (early, late), number of conceptions, anomalous live young, growth-weight and height was inspected.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:yes

Details on maternal toxic effects:
Acidosis was reported in the maternal animals treated with the test substance

Control /NH4Cl /Na salicylate (500mg/kg)
Maternal death(%): 0 /0 /0
No.of conceptions: 136 /122 /288

Effect levels (maternal animals)

Dose descriptor:
Effect level:
< 8.9 mg/kg bw/day (nominal)
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Details on embryotoxic / teratogenic effects:
Control /NH4Cl /Na salicylate(500mg/kg)

Resorption-early(%): 6 /15 /15
Resorption-late(%) : 0 /1 /11
Anomalous live young(%): 0 /0 /14
Growth weight(g): 3.2 /2.0 /2.0
Growth height(mm):38 /27 /27

The effects of this substance on foetal survival and growth were considered a consequence of maternal acidosis by the authors. They argued that "The amount of 2.5 mEq/24 hours ammonium chloride consumed by pregnant rat in the study is sufficient to cause metabolic acidosis rats weighing between 250 and 300 g. Although, no statistical and/or background data were shown, it is agreeable. No foetus with malformations was observed in this substance-treated group. This substance has no teratogenicity at this dose level.

Effect levels (fetuses)

Dose descriptor:
Effect level:
< 8.9 mg/kg bw/day (nominal)
Basis for effect level:
other: fetotoxicity

Fetal abnormalities

not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

The authors regarded the decrements in foetuses length and weight as meaningfull findings, but considered them a corollary of maternal effects. The author referred to these effects as "the inhibition of growth by a metabolic acidosis".

Applicant's summary and conclusion