Dihydrogen [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']nickelate(2-)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Remarks:

Read across data

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from secondary source

Data source

Reference

Reference Type:

other: Secondary literature

Title:

Acute dermal toxicity of the test substance Theophylline in rats.

Author:

SIDS INITIAL ASSESSMENT REPORT

Year:

2003

Bibliographic source:

OECD SIDS, SIDS INITIAL ASSESSMENT REPORT, 2003

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Theophylline

Cas Number:

58-55-9

Molecular formula:

C7H8N4O2

IUPAC Name:

Theophylline

Test material form:

solid

Details on test material:

IUPAC name-Theophylline
Molecular formula :C7H8N4O2
Molecular weight :180.166 g/mol
Substance type:organic
Physical state:White solid

Specific details on test material used for the study:

IUPAC name-Theophylline
Molecular formula :C7H8N4O2
Molecular weight :180.166 g/mol
Substance type:organic
Physical state:White solid

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

Not specified

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

olive oil

Details on dermal exposure:

Not specified

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female Wistar rats

Control animals:

not specified

Details on study design:

not specified

Statistics:

not specified

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths were observed

Clinical signs:

other: Not specified

Gross pathology:

Not specified

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The acute dermal toxicity in rats was noted to be >2000 mg/kg bw, as there were no mortalities observed in any of the animals.

Executive summary:

Acute dermal toxicity study was conducted for the read across substance Theophylline (CAS no.: 58 -55 -9, E.C. no. 200 -385 -7) in five male and female Wistar rats. Rats were exposed to the test substance via dermal route. The test substance was exposed to the animals at concentration 2000mg/kg bw in olive oil, for 24 hours. The test site was then covered with semiocclusive patch. The patch was then removed after 24 hours and the application site was washed. The animals were observed for clinical signs of toxicity and mortality for 14 days. No clinical signs of toxicity and no mortalities were observed in any of the animals. Hence, the LD50 concentration was considered to be >2000mg/kg bw, when rats were treated with the given test substance and thus was considered to be "Not classified", as per the CLP criteria.