Silver chloride

Endpoint summary

Description of key information

A reliable study available for acute oral toxicity of silver chloride is available (rat, LD50 > 5510 mg/kg bw).
Testing for acute inhalation toxicity is scientifically unjustified for AgCl (see respective justification for waiving).

Testing for acute dermal toxicity is scientifically not justified for AgCl, because of the low potential for any dermal penetration (see section on toxicokinetics) and the generally low acute, systemic toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-09-27 to 1988-10-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Guideline study. At the time of the study conduct, GLP was not compulsory. However, the study was conducted in accordance with the principles of GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: BOR: WISW (SPFCpb)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Uinkelmann Versuchstierzucht GmbH & Co. KG., Borchen
- Age at study initiation: 8 weeks (males) and 9 weeks (females)
- Weight at study initiation: 151 - 161 g (males) and 135 - 155 g (females)
- Fasting period before study: 16 hours before treatment
- Housing: in Macrolon cages, type II, individually housing
- Diet: ad libitum (Standard diet, ssniff R, "Special Diet for Rats")
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22.5
- Humidity (%): 45 - 65
- Photoperiod: 12 hours dark/light cycle

Route of administration:

oral: gavage

Vehicle:

other: Mixture of Witepsol H 15 and Miglyol 812 1 : 1.2 w/w; Miglyol 812 (Mittelkettige Triglyceride DAB 9) and Vitepsol H 15 (Hartfett DAB 9), both supplied by ASTA-Pharma AG, Frankfurt/M. 1

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 237 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 21.5 mL/kg

Doses:

5110 mg/kg body weight

No. of animals per sex per dose:

5 male and 5 female rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 or 21 days after administration
- Frequency of observations and weighing:
The animals were continuously observed for the first 4 to 6 hours after administration and then once daily. The nature of the toxicity as well as the onset, the intensity and the duration of the signs were recorded.
Mortality was checked twice daily. Time of death and number of dead animals per dose were documented.
The body weights were recorded at the beginning and also 7 and 14 days after administration. In one male and one female rat the body weights were also determined on day 21.
- Necropsy of survivors performed: yes; at the end of the observation period the animals were sacrificed with C02. A gross necropsy was performed on all animals deceased intercurrently or sacrificed at the end of the observation period. Macroscopic examination included external appearance, body orifices, body cavities (thoracic and abdominal) and their contents.

Statistics:

no data

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 110 mg/kg bw

Mortality:

Deaths did not occur.

Clinical signs:

other: The signs of toxicity were slight to moderate hypokinesia, stilted gait, piloerection, sunken sides, vocalization on handling, red crusted noses, and diarrhea with black discoloured feces. Individual rats additionally showed chromodacryorrhea and strenuou

Gross pathology:

At necropsy no changes were recorded.
Brain and spinal cord of the female rat that did not recover completely were examined microscopically, but changes could not be detected.

Other findings:

Diarrhea was caused by the vehicle alone, too.

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The LD 50 values for silver chloride tested in a single dosewere above 5110 mg/kg for male and female rats (limit test).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

A reliable study available for acute oral toxicity of silver chloride is available (rat, LD50 > 5510 mg/kg bw). Testing for acute inhalation toxicity is scientifically unjustified for AgCl (see respective justification for waiving). Testing for acute dermal toxicity is scientifically not justified for AgCl, because of the low potential for any dermal penetration and the generally low acute, systemic toxicity. In consequence, silver chloride does not require classification for acute toxicity endpoints.