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Description of key information

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
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no
Specific details on test material used for the study:
Batch# 1776194
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Animals were received from Charles River, Raleigh NC, on 15 Oct 2015 and 05 Nov 2015. Following an acclimation period of at least five days, three male and three healthy, non-pregnant and nulliparous female Sprague Dawley rats were assigned to treatment groups without conscious bias.
The animals were born on 19 Aug 2015 and 09 Sep 2015. The pretest body weight range was
250 - 258 grams for males and 200 - 207 grams for females. The weight variation of the animals used did not exceed ±20% of the mean body weight of the previously dosed animals within a sex.
The animals were identified by cage notation and indelible body marks, and housed in suspended wire cages; five per sex per cage prior to dosing and three per sex per cage following dosing. Absorbent paper bedding was placed beneath the cages and changed at least three times per week. Fresh PMI Rat Chow (Diet #5012) was freely available except for 16-20 hours prior to dosing. Water was available ad libitum. The animal room, reserved exclusively for rats on acute tests, was temperature controlled, had a 12-hour light/dark cycle, and was kept clean and vermin free.
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test article was used as received and the dose was based on the sample weight as calculated from the specific gravity. A single dose was administered orally by syringe and dosing needle to three female rats and three male rats.
Doses:
Dose level of 2000 mg/kg was administered to three female rats and three male rats.
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
In Vivo – Animals were observed at 15 minutes, 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects and twice daily for mortality. Body weights were recorded immediately pretest, weekly, at death and at termination in the survivors.
Post Mortem – All animals were humanely sacrificed using CO2 and were examined for gross pathology following study termination.
Analysis of Data
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 918 mg/kg bw
Based on:
act. ingr.
Remarks on result:
other: LD50 was calculated for the registered substance based on its content in the tested product (45.9%).
Mortality:
Two female rats survived following a single 2000 mg/kg oral dose. One animal was found dead on Day 1.All three male rats survived following a single 2000 mg/kg oral dose.
Clinical signs:
Female
Prior to death, abnormal physical signs including piloerection, lethargy, and dyspnea were observed. Among the survivors, prostration, lethargy, sagging eyelids, and piloerection were observed.
Male
Abnormal physical signs including piloerection, ataxia, chromorhinorrhea, chromodacryorrhea, sagging eyelids, wetness and red staining of the nose/mouth area, soiling of the anogenital area, hunched posture, dyspnea, bloated abdomen, tachypnea and emaciation were observed.
Body weight:
Female
Body weight loss was observed in the animal that died and the survivors gained body weight by study termination.
Male
Two animals gained weight by study termination and one animal lost weight.
Gross pathology:
Female
The gross necropsy, of the animal that died, revealed red staining of the nose/mouth area and abnormalities of the gastrointestinal tract. No observable abnormalities were observed among the survivors.
Male
The gross necropsy revealed emaciated appearance, bloated abdomen, chromodacryorrhea, chromorhinorrhea, and abnormalities of the gastrointestinal tract.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The oral LD50 determined for Catalyst 1786B by OECD 423 method is greater than 2000 mg/kg b.w. The oral LD50 determined for Propan-1-ol,2-amino-2-methyl-, 4-methylbenzenesulphonate was 918 mg/kg b.w..
Executive summary:

The oral LD50 determined for Catalyst 1786B by OECD 423 method  is greater than 2000 mg/kg b.w. The oral LD50 determined for Propan-1-ol,2-amino-2-methyl-, 4-methylbenzenesulphonate was 918 mg/kg b.w. resulting in GHS Cat. 4 classification for oral toxicity.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
918 mg/kg bw

Additional information

Justification for classification or non-classification

The oral LD50 determined for Catalyst 1786B by OECD 423 method  is greater than 2000 mg/kg b.w. The oral LD50 determined for Propan-1-ol,2-amino-2-methyl-, 4-methylbenzenesulphonate was 918 mg/kg b.w. resulting in GHS Cat. 4 classification for oral toxicity.