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Diss Factsheets

Administrative data

Description of key information

Most animals survived a dose of 15000 mg/kg via gavage with only minor effects. Only 1 male died

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:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: early study with short report but giving the essential details of the study; no GLP; poor substance characterisation
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Remarks:
pre-dates GLP regulation
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: CFY
Sex:
male/female
Details on test animals or test system and environmental conditions:
animals were starved overnight before treatment
Route of administration:
oral: gavage
Vehicle:
other: aqueous tragacanth (0,5%)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 %
- Amount of vehicle (if gavage): 50 mL/ kg
Doses:
15000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Effect level:
> 15 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: extreme dose and volume
Mortality:
one male died within 21 hours after treatment
Clinical signs:
other: shortIy after doSsing: lethargy, piloerection and diarrhoea.
Gross pathology:
no adverse effects
Other findings:
none
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
fhe acute median lethal oral dose (LDso) to rats of the test item was fourd to be: greater than 15 g/kg bodyweight
Executive summary:

EXPERIMENTAL PROCEDURE

Rats of the CFY strain in the weight range 142 to 174 g were starved overnight before treatment with the test item.

The test item w

as prepared as a 30% suspension in aqueous gum tragacant·h (0.5%) and administered by oral intubation at a dosage volume of 50 ml/kg bodyweight. Rats treated with the vehicle alone served as controls.

During the observation period of 14 days a record was kept of all mortalities and signs of toxicity. All rats that died were examined macroscopically in an attempt to identify the target organs, and those animals surviving terminally were similarly examined to detect possible residual damage.

RESULTS

Ten rats (five males and five females) were treated with the test item at

a dosage level of 15 g/kg bodyweight.

Signs of reaction to treatment, observed shortly after dosing, consisted of lethargy, piloerection and diarrhoea. One male rat died witlln 21 hours of treatment.

Autopsy did not reveal any specific cause of death.

Recovery of survivors, as judged by external appearance and behaviour, was apparently complete within two days of treatment. This observation was substantiated by normal bodyweight gains, compared with controls and normal autopsy findings.

CONCLUSION

The acute median lethal oral dose (LD50) to rats of he test item

was found to be: greater than 15 g/kg bodyweight.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
15 000 mg/kg bw
Quality of whole database:
2 (reliable with restrictions)

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Even at the extreme dose and application volume of 15000 mg/kg bw or 50 mL/kg bw, resp. rats showed mostly only minor transient signs of toxicity.and recovered within two days completely.


Justification for selection of acute toxicity – oral endpoint
only available study

Justification for classification or non-classification

no classification

the dose exceeded the current limit dose clearly and nevertheless caused only minor signs of toxicity in 9 of 10 animals