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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: sperm mobility and (dehydro) ascorbic acid in testes were investigated
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Poorly documented study with limited data reported. For read-across justification see Section 13.

Data source

Reference
Reference Type:
publication
Title:
Effect of phthalic anhydride on gonads [in Russian].
Author:
Protsenko EI
Year:
1970
Bibliographic source:
Gig. Sanit. 35, 127-130

Materials and methods

Principles of method if other than guideline:
Groups of 6 male rats were exposed to 0, 0.02, 0.2, or 1 mg/m³ phthalic anhydride for 45 days, 24 hours/day. Testes were dissected in the recovery phase, two weeks after the end of dosing. The amount of ascorbic acid, dehydroascorbic acid, RNA and DNA were investigated in the testes. Sperm mobility was investigated with a light-microscope.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Phthalic anhydride
- Molecular formula (if other than submission substance): C8 H4 O3
- Molecular weight (if other than submission substance): 148.12
- Smiles notation (if other than submission substance): O=C(OC(=O)c1cccc2)c12
- InChl (if other than submission substance): 1S/C8H4O3/c9-7-5-3-1-2-4-6(5)8(10)11-7/h1-4H
- Structural formula attached as image file (if other than submission substance): see Fig. “85-44-9 structure.png”
- Analytical purity: 98.8 %

Test animals

Species:
rat
Strain:
not specified
Sex:
male

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure (if applicable):
not specified
Vehicle:
not specified
Details on mating procedure:
not applicable
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Exposure period: 45 w, 24 hours a day
Frequency of treatment:
daily
Details on study schedule:
not applicable
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 0.02, 0.2, or 1 mg/m³
Basis:
nominal conc.
No. of animals per sex per dose:
6 animals per dose
Control animals:
yes, concurrent no treatment

Results and discussion

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

The amount of ascorbic acid and dehydroascorbic acid in the testes decreased and the amount of RNA increased.

Control 0.02 0.2 1 mg/m3
Ascorbic acid (mg%)
31,25±1,36 29,51±0.86 24,70±0,57 19,19±0,48
Dehydroascorbic acid
2,39±0,11 1,90±0,13 140±0,14 0,29±0,05
RNA (mg%)
1,5±0,32 1,78±0,24 1,72±0,25 2,43±0,25

Sperm mobility:

Control: 82 minutes (no further data, no SD given)
0.02 mg/m3: no data
0.2 mg/m3: 60 minutes (no further data, no SD given)
1 mg/m3: 40 minutes (no further data, no SD given)

Applicant's summary and conclusion

Executive summary:

Groups of 6 male rats were exposed to 0, 0.02, 0.2, or 1 mg/m³ phthalic anhydride for 45 days, 24 hours/day. Testes were dissected in the recovery phase, two weeks after the end of dosing. The amount of ascorbic acid, dehydroascorbic acid, RNA and DNA were investigated in the testes. Sperm mobility was investigated with a light-microscope.

As a result the amount of ascorbic acid and dehydroascorbic acid in the testes decreased in the testes, and the amount of RNA increased in the testes, no further data for sperm mobility

reference: Protsenko, 1970