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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1997-09-12 to 1997-09-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Acetic acid, 2-sulfo-, mono-C12-14(even numbered)-alkyl esters, sodium salt
EC Number:
939-512-2
Cas Number:
85681-55-6
IUPAC Name:
Acetic acid, 2-sulfo-, mono-C12-14(even numbered)-alkyl esters, sodium salt
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): LATHANOL LAL
- Purity: 100 % (UVCB)
- Lot/batch No.: Lot #7-20041
- Substance type: white powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Sprague-Dawley, Indianapolis, Indiana
- Age at study initiation: 6 to 10 weeks
- Weight at study initiation: 202 - 220 g
- Fasting period before study: Yes, overnight
- Housing: Individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
Temperature, humidity and light controlled room (DHEW publication No. 86-23 (NIH))

IN-LIFE DATES: From: 1997-09-12 To: 1997-09-26

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 33%
- Dosage volume: 1.01 - 1.10 g
Metal dosing cannula
Doses:
5 g/kg bw (1650 mg active/kg bw)
No. of animals per sex per dose:
five males/five females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations - frequently on day of dosing (1, 2.5 and 4 hours) and once daily thereafter; bodyweights on study initiation, at 7 and 14 days post-administration and at death.
- Necropsy of survivors performed: yes
Statistics:
Calculations of the LC50 and 95% confidence limits: Method of moving averages, Weil CC (1952) table for convenient calculations of median effective dose (LD50 and ED50) and instruction in their use. Biometrics, 8.

Results and discussion

Preliminary study:
Not performed
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
< 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
< 1 650 mg/kg bw
Based on:
act. ingr.
Mortality:
8/10 rats died by Day 1 of the post-administration period. The remaining two rats (2 x male) dosed with the test material survived until Day 14 of the post-administration period.
Clinical signs:
salivation and hypoactivity were observed by the 2.5 and 4 hour observation periods for the three males that died. There were no clinical signs of toxicty observed in any of the females.
Body weight:
Body weight of the two surviving animals increased up to Day 14.
Gross pathology:
Occurred only in animals that died during the course of the study:
External observations: bloody muzzle and wet tail
Internal observations: confined to the gastrointestinal tract, stomach and small intestine distended with gas and fluid, small intestine appeared red with haemorrhagic sites.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral administration of a 33% solution of the test material (5 g/kg bw) resulted in an LD50 <1650 mg active/kg bw.
Executive summary:

The acute oral toxicity of the test material as a 33% solution in water was assessed in male and female rats in accordance to OECD Guideline No. 401. Five male and five female rats were dosed by oral gavage with 5000 mg/kg bw (1650 mg active/kg) . After a 14 day observation period there were 8/10 mortalities. There were no treatment related effects observed on bodyweight or at gross necropsy of the remaining two male rats. The LD50 was < 1650 mg active/kg bw.

In accordance with Regulation (EC) No. 1272/2008 the substance is classified for acute toxicity by the oral route. In the absence of a derived LD50 value the substance is labelled as Category 4.