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EC number: 274-570-6
CAS number: 70321-86-7
- LD50 acute oral toxicity (male and
female; rat): > 7,750 mg/kg bw (BASF, 784965, 1978; reliability score:
- LD50 acute dermal toxicity (male and
female; rat): > 2000 mg/kg bw (BASF, 934003, 1993; reliability score:
1 (OECD 402))
Table 1: Table of Body weights (acute oral toxicity)
Dose (mg/kg bw)
187 ± 7.1
173 ± 2.3
175 ± 3.7
181 ± 1.6
184 ± 4.1
179 ± 1.3
175 ± 2.8
163 ± 4.5
251 ± 9.6
233 ± 9.8
250 ± 8.3
237 ± 1.8
219 ± 6.1
216 ± 5.2
210 ± 7.5
194 ± 6.6
289 ± 17.0
285 ± 11.6
298 ± 17.2
288 ± 8.7
248 ± 7.0
239 ± 4.0
233 ± 9.7
217 ± 7.0
Table 1: Table of mean body weights (n = 5); acute dermal toxicity
2,000 (mg/kg bw)
223 ± 9.0
269 ± 10.7
248 ± 14.0
319 ± 9.3
266 ± 15.7
Acute oral toxicity
In a standard acute oral toxicity
study performed similarly to OECD TG 401, groups (5 rats/ dose/ sex) of
7 - 8 weeks old Tif Rai f (SPF) rats were administered the test
substance (no data on purity) via gavage after an overnight fasting
period. The test substance was administered at doses of 1,000, 2,150,
4,640 and 7,750 mg/kg bw in polyethylene glycol (400). Animals were
subsequently observed for a period of 14 day in which time clinical
signs of toxicity, body weights changes and cases of mortality were
Death did not occur at any dose level.
Hence the LD 50 is higher than 7,750 mg/kg bw. Registered clinical signs
of toxicity seen in all groups were sedation, dyspnoea, exophthalmoses,
ruffled fur, curved body position and diarrhoea (seen in the highest
dose only). Clinical signs were fully reversible within 10 days in all
animals. Body weight development was normal and at necropsy, no
deviations from normal morphology were found.
This study is suitable for assessment
of acute oral toxicity as it was performed using a protocol which is
similar and equivalent to the obsolete OECD 401 guideline.
Acute dermal toxicity
In an acute dermal toxicity study,
groups of young adult Tif RAI f (SPF) rats, 5/ sex/ dose were dermally
exposed to the test substance (> 99 % pure) in 0.5 % (w/v) carboxymethyl
cellulose in 0.1 % (w/v) aqueous polysorbate 80 for 24 hours to at least
10 % of the total body surface at the limit dose of 2,000 mg/kg bw.
Substance application was performed under a semi-occlusive dressing.
Animals then were observed for 14 days.
No mortalities occurred. LD 50 thus
lies higher than 2,000 mg/kg bw. Treatment related clinical signs of
toxicity were limited to piloerection which was fully reversible within
1 day. There were no treatment related necropsy findings or changes in
This study is suitable for assessment
of acute dermal toxicity as it was performed according to OECD 402
(1987) and GLP standards.
Classification, Labelling, and Packaging
Regulation (EC) No. 1272/2008
The available experimental test data are
reliable and suitable for the purpose of classification. Based on the
criteria laid down in Regulation (EC) No.1272/2008, as amended for
time in Directive EC 944/2013, classification for acute toxicity
is not warranted.
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