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Toxicological information

Additional toxicological data

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Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
9th March 1999 to 12th March 1999
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The work was undertaken in 1999 and was not conducted to GLP although a statement of authentication is included. The study was not conducted to a recognised guideline as none are known to exist for this type of study, but was conducted in accordance with the method published in 1974 by Morikawa et al, a full description of which is included within the report. The results are not well reported being restricted to a summary table that does not describe the effects on individual animals and thus cannot be used to assess the dermal irritation potential of the substance in accordance with appropriate criteria. Neither the batch number nor the purity of the substance is reported in the study and the study was conducted up to a maximum concentration of 40% of the nominal concentration of the test material. As the substance was not tested up to its full concentration, and that the results are not adequately reported the study, it cannot be considered to be reliable in assessing the dermal irritation potential of the test material.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Type of study / information:
Phototoxic Potential:
The objective of the study was to determine the skin irritancy potential of the test material with and without UV radiation.
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The phototoxic potential of the test material was assessed in Hartley albino guinea pigs. The test material was applied to the skin at concentrations of 40, 20, 10 and 5 % (w/w) on either side of the test animal. After application, one side was covered with foil, the other was irradiated. The test sites were observed 24, 48 and 72 hours after application and the dermal reactions recorded. The method was based on the study Morikawa F et al (1974) University of Tokyo Press, Tokyo Japan: 529-527.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Results and discussion

Any other information on results incl. tables

Table 2: Summary of results

Concentration (%)

Dermal Irritation (non-irradiated)

Dermal Irritation Irradiated

40

20

10

5

40

20

10

5

Primary Irritation Index

0.13

0

0

0

0.75

0.38

0

0

Number of reactions

1/8

0/8

0/8

0/8

6/8

3/8

0/8

0/8

Classification

±

-

-

-

+

+

-

-

Applicant's summary and conclusion

Conclusions:
Under the conditions of the test, it was concluded that the test material was not a primary skin irritant up to a concentration of 20 % and non-phototoxic up to a concentration of 10 % in the Hartley guinea pig.
Executive summary:

The phototoxic potential of the test material was assessed in Hartley albino guinea pigs. The test material was applied to the skin at concentrations of 40, 20, 10 and 5 % (w/w) on either side of the test animal. After application, one side was covered with foil, the other was irradiated. The test sites were observed 24, 48 and 72 hours after application and the dermal reactions recorded. The method was based on the study Morikawa F et al (1974) University of Tokyo Press, Tokyo Japan: 529-527. Under the conditions of the test, it was concluded that the test material was not a primary skin irritant up to a concentration of 20 % and non-phototoxic up to a concentration of 10 % in the Hartley guinea pig.