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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
seven concentrations tested, two higher then limit dose, documentation sufficient but not very detailed
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Naphthalene-2-sulphonic acid
EC Number:
204-375-3
EC Name:
Naphthalene-2-sulphonic acid
Cas Number:
120-18-3
Molecular formula:
C10 H8 O3 S
IUPAC Name:
naphthalene-2-sulfonic acid
Details on test material:
- Name of test material (as cited in study report): beta-Naphthalinsulfonsäure, Picaltal fest
- Physical state: solid
- Analytical purity: technical grade (no further data)

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gassner
- Weight at study initiation: mean males: 251 g (224-286 g), mean females: 195 g (170-234g)
no further data


ENVIRONMENTAL CONDITIONS
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 16 %
- Amount of vehicle (if gavage): 5-20 ml/kg of the 16% aqueous emulsion

MAXIMUM DOSE VOLUME APPLIED:
5-20 ml/kg of the 16% aqueous emulsion

Doses:
800, 1000, 1250, 1600, 2000, 2500, 3200
No. of animals per sex per dose:
5
Control animals:
not specified
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
Statistics:
no data

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 1 400 mg/kg bw
Mortality:
no death occured at the 800 mg/kg dose level. 0/5 male and 1/5 female animals died at 1000 mg/kg , 2/5 male and 1/5 female animals died at 1250 mg/kg, 5/5 male and 1/5 female animals died at 1600 mg/kg, 5/5 male and 3/5 female animals died at 2000 mg/kg bw . All animals at 2500 and 3200 mg/kg died.
Clinical signs:
Clinical findings in all animals were dyspnea, convulsions and staggering
Gross pathology:
At necropsy of the animals that died, general congestive hyperemia, dilatation of the heart, hydrothorax, slight ascites, hemorrhagic slough eschar in the stomach and hematinic intestinal content were observed. Animals that died delayed and survivors of the 1600 and 2000 mg/kg bw groups were emaciated.

Any other information on results incl. tables

800 mg/kg bw:
All animals survived the treatment until necropsy. They showed clinical findings until day 10 after treatment. At necropsy the stomach wall was thickened and whitish.


1000 mg/kg bw:
With the exception of 1 female rat that died 48 h after treatment all animals survived the treatment until necropsy. The surviving animals showed clinical findings until day 10
after treatment. Necropsy findings of 2 survivors showed black eschar in the stomach.

To a lower extend than higher dosed surviving animals, the survivors of this group showed emaciation and their stomachs were dilated. The stomach wall was thickened whitish, and yellowish-white slough eschar was found. The stomach was dilated. The perirenal adipose tissue was partially lost.


1250 mg/kg bw:
One female rat died after 24 h and one male after 48 h. Another male rat died after 3 days, all other animals survived the treatment until necropsy. Again clinical findings were recorded until day 10 after treatment and at necropsy of the surviving animals the same findings as in
the 800 and 1000 mg/kg bw groups were seen to a larger extend.

1600 mg/kg bw:
One female rat died 10 days after treatment, three male rats died after 24 h and again one male animal died 48 h after treatment. All males were dead 3 days after treatment. The surviving female animals showed no clinical findings after 9 days. Necropsy findings of the animals that survived until sacrifice and of those that died were the same as described before.

2000 mg/kg bw:
4/5 male rats died after 24 h and 2 days after treatment all male rats were dead. 2/5 female rats died after 24 h and again one female rat died 3 days after treatment. The surviving female animals showed no clinical findings after 9 days. Necropsy findings of the females that survived until sacrifice and of those animals that died were the same as described before: the stomach was strongly dilated and filled with thin paste-like content. Stomach areas showed yellowish-white eschar and were partially thickened, folding was not seen. The perirenal adipose tissue was completely lost.

2500 mg/kg bw:
All male rats and 3 of the females died within 24 h after treatment. Again one female died 48 h after treatment and all females were dead 3 days after treatment. Necropsy findings of the animals found dead were already described above.

3200 mg/kg bw:
All females and four males were dead 24 h after treatment. The last male died 48 h after treatment. Necropsy findings of the animals found dead were already described above.

Applicant's summary and conclusion

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