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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:
key study
Study period:
From 13 October 1987 to 4 November 1987.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study performed similarly to OECD guideline No. 401 but no data on GLP compliance. Only males are tested.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Kanpogyo Notification No. 39, Yakuhatsu Notification No. 229, and 59 Kikyoku Notification No., 85, dated 31 March 1984
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Trifluoromethanesulphonic acid
EC Number:
216-087-5
EC Name:
Trifluoromethanesulphonic acid
Cas Number:
1493-13-6
Molecular formula:
CHF3O3S
IUPAC Name:
trifluoromethanesulfonic acid
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Trifluoromethanesulfonic acid.

Test animals

Species:
rat
Strain:
Wistar Kyoto (WKY)
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Shizuoka Agricultural Cooperative Association for Laboratory Animals
- Age at study initiation: 5 weeks
- Weight at study initiation: 108.7 +/-3.4 g
- Fasting period before study: 17 hours prior to administration
- Housing: by groups of 5 in 310 mm W x 400 mm D x 200 mm H cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-25°C
- Humidity (%): 45-65%
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark /12 hrs light

IN-LIFE DATES: From: 13 October 1987 To 4 November 1987.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: see Table 7.2.1/1
- Amount of vehicle (if gavage): 1 mL/100 g
- Justification for choice of vehicle: no data

MAXIMUM DOSE VOLUME APPLIED: no data

DOSAGE PREPARATION:
The test substance was diluted with distilled water to prepare the administration solutions at the prescribed concentrations as needed

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
As a preliminary test, 3 to 4 animals were administered 2000 and 500 mg/kg of the test substance. 3 of the 4 cases in the 2000 mg/kg group died, but no deaths were observed in the 500 mg/kg administration group. Based on these results, a dosage of 700 mg/kg was used as the standard and a common ratio of 1.3 established to set dosages within the range of 539 to 2000 mg/kg bw.
Doses:
0, 539, 700, 910, 1183, 1538 and 2000 mg/kg bw.
No. of animals per sex per dose:
10 males/dose

Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for death or overt signs of toxicity several times on the day of administration, and then at least once per day from the following day onward. Individual bodyweights were recorded prior to dosing on Day 0 and on days 3, 7, 10 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weigh and histopathology
Statistics:
LD50 value was calculated by the Probit method. The weights of the administration groups with at least 2 survival cases were assayed by determining the difference in average values between the control group and each administration group by means of a Student’s t-test or Welch’s test.

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 1 605.3 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 402.1 - <= 1 941.8
Mortality:
- At 2000 mg/kg: 7/10 of dead animals
- At 1538 mg/kg: 6/10 of dead animals
-At 1183 mg/kg: 1/10 of dead animals
- At 910, 700 and 539 mg/kg: 0/10 of dead animals for each tested doses.
Clinical signs:
other: - At 2000 and 1538 mg/kg: decrease in spontaneous movement, crawling, sedation and emaciation were observed. - At 1183 and 910 mg/kg: decrease in spontaneous movement and sedation were observed - At 700 and 539 mg/kg: decrease in spontaneous movement was
Gross pathology:
- The necropsies of the fatal cases revealed gastric hemorrhaging, perforation, clouding and hyperemia of the small intestine, blackening and hypertrophy of the spleen, petechial hemorrhaging of the thymus, hemorrhaging of the bladder, and increase in pleural effusion.
- The necropsies of the survival cases revealed gastric erosion, scarring, thickening, adhesion of the stomach and liver, and thickening of the duodenum in the groups administered 1183 mg/kg or more.
Other findings:
- Histopathology:
Histopathological examinations revealed submucosal cellular infiltration in the stomach and small intestine. In strongly stimulated cases, adhesion of the stomach and liver reaching the muscle layer, serous membrane, and outside the serous membrane was observed. An extreme decrease in lymphocytes in the spleen was also observed.

Any other information on results incl. tables

Table 7.2.1/2: Autopsy findings in male rats treated with trifluoromethanesulfonic acid:

Dose (mg/kg)

0

539

700

910

1183

1538

2000

No. Of rats used

10

10

10

10

10

10

10

No. Of rats found dead

0

0

0

0

1

6

7

FINDINGS

Thymus:

-Petechia

0

0

0

0

1

0

0

Stomach:

-Perforation

-Hemorrhage

0

0

0

0

 

0

1

 

5

5

 

4

7

Small intestine:

-Cloudy white

-hyperemia

0

0

0

0

 

 

0

 

0

 

 

0

 

0

 

 

3

 

3

Spleen:

-Hypertrophy

-Black in color

0

0

0

0

 

0

0

 

0

0

 

2

3

Urinary bladder:

-Hemorrhage

-Pleural effusion increase

0

0

0

0

 

 

0

0

 

 

0

4

 

 

1

4

Advanced autolysis

0

0

0

0

0

1

0

Terminal killed

 

 

 

 

 

 

 

Stomach:

-Erosion

-Scar

-Thickening

0

0

0

0

 

0

0

7

 

3

1

4

 

0

1

3

Stomach and liver:

-Adhesion

0

0

0

0

0

1

1

Duodenum:

-Thickening

-No abnormalities detected

 

0

10

 

0

10

 

0

10

 

0

10

 

4

2

 

1

0

 

1

0

 

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Under the test conditions of this study, the acute median lethal dose (LD50) of trifluoromethanesulfonic acid was 1605.3 mg/kg body weight in the Wistar Kyoto (WKY) strain male rat. Based on this result, trifluoromethanesulphonic acid is classified as Harmful if swallowed in category 4, H302 according to the regulation (EC) No. 1272/2008 (CLP) and as Xn-R22 according to Annex VI of the Directive 67/548/EEC.
Executive summary:

In an acute oral toxicity study (KOBAYASHI, 1988) performed similarly to OECD guideline N° 401, groups of fasted Wistar Kyoto male rats (10/dose) were given a single oral dose of trifluoromethanesulphonic acid by gavage at the doses of 0 (vehicle only), 539, 700, 910, 1183, 1538 and 2000 mg/kg bw and observed for 14 days. Mortality and clinical signs were checked just after administration at 1, 2, 6 hours after dosing, and daily for 14 days. Body weight was recorded on days 0, 1, 2, 4, 7 and 14.

 

No males died at 539, 700 and 910 mg/kg bw whereas 1/10, 6/10 and 7/10 animals died when dosed at 1183, 1538 and 2000 mg/kg bw respectively.

Decrease in spontaneous movement, crawling, sedation and emaciation were observed but they were reversible.

All animals treated at 1183 mg/kg bw and more showed suppression of weight gain during the study.

Gastric erosion, scarring, thickening, adhesion of the stomach and liver and thickening of the duodenum were observed at necropsy. Histopathological examinations revealed submucosal cellular infiltration in the stomach and small intestine. In strongly stimulated cases, adhesion of the stomach and liver reaching the muscle layer, serous membrane, and outside the serous membrane was observed. An extreme decrease in lymphocytes in the spleen was also observed.

 

Under the conditions of this test, the Oral LD50 male rats = 1605.3 mg/kg (with 1402.1-1941.8 95% C.I.).

Based on these results, trifluoromethanesulphonic acid is considered as harmful if swallowed in category 4; H302 according to the regulation (EC) No. 1272/2008 (CLP) and as Xn, R22 according to the directive 67/548/EEC.

This acute oral study is classified as acceptable. It satisfies the guideline requirement for an acute oral study in the rats.