Potassium 2-(4-chloro-2-methylphenoxy)propionate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7.11.2006 - 11.12.2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

yes (incl. QA statement)

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Non-LLNA in-vivo study avaliable.

Test material

Test material information

Constituent 1

Reference substance name:

Mecoprop

EC Number:

230-386-8

EC Name:

Mecoprop

Cas Number:

7085-19-0

Molecular formula:

C10H11ClO3

IUPAC Name:

2-(4-chloro-2-methylphenoxy)propanoic acid

impurity 1

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Test material form:

solid

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

50% solution in the amoint 0.5 ml

No. with + reactions:

9

Total no. in group:

12

Results 2

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

Tested substance was not used.

No. with + reactions:

0

Total no. in group:

6

Results 3

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

positive control

Remarks on result:

not measured/tested

Applicant's summary and conclusion

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Executive summary:

During the readings after 24, 48 and 72 hours after the end of exposure, in the skin of animals in the control group, in the area where the test material, no pathological changes were observed.

 

In the course of reading after 24 hours from the end of the exposure, on the skin of animals from exposed group, in the area where the test material was found: mild or macular Erythema in seven animals (male # 1, 6, 7, 8, 10, 11 1 12), as well as moderate or confluent to Erythema in two animals were observed (male # 3 and 9). In other animals, from the exposed group there were no pathological changes observed.

 

In the course of reading after 24 hours from the end of the exposure, on the skin of animals from exposed group, in the area where the test material was found: Erythema in six animals (male no.# 1, 6, 7, 8, 11 and 12), moderate or confluent redness on three animals (male no.# 3, 9 and 10). In addition, three male (# 3, 7 and 9) it was dry, the epidermis. In other animals, from the exposed group there were no pathological changes observed.

 

In the course of reading after 72 hours from the end of the exposure on the skin of animals from exposed group stated: mild or macular Erythema in three animals (male no.# 7, 8, and 12) and moderate or confluent redness on three male (no.# 3, 9 and 10). In addition, the skin dryness were found in five animals (male # 3, 6, 7, 9 and 11). In other animals from exposed group there was no pathological changes observed.

 

On the basis of the obtained results, it should be noted that allergic skin reactions occurred in nine of 12 animals from the exposed group, which represents 75% of the animals of the group.

During the test in all the animals in both: the control group and exposed group increase in body weight has been observed.

During the test no changes in the behavior were observed in both: the control group and exposed group.