Tricarbonyl(methylcyclopentadienyl)manganese

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

environmental conditions not mentioned. Exposure was for 24 hours rater than the recommended time of 4 hours. Skin on two sides of the rabbit is tested, but one of the sides is abraded, testing was not carried out through reversibility (up to 14 days)..

GLP compliance:

no

Remarks:

Study conducted prior to GLP guidelines.

Test material

Test material information

Constituent 1

Reference substance name:

Tricarbonyl(methylcyclopentadienyl)manganese

EC Number:

235-166-5

EC Name:

Tricarbonyl(methylcyclopentadienyl)manganese

Cas Number:

12108-13-3

Molecular formula:

C9H7MnO3

IUPAC Name:

tricarbonyl(methyl-η5-cyclopentadienyl)manganese

Details on test material:

- Name of test material: methylcyclopentadienyl manganese tricarbonyl
- Physical state: Amber liquid
- Lot/batch No.: 548-76

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Not mentioned
- Age at study initiation: Not mentioned
- Weight at study initiation: 1.9-2.3 kg
- Housing: No data
- Diet: No data
- Water : No data
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS
Not reported.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: Two sides per rabbit were used, one abraded and other intact.

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): 100%

Duration of treatment / exposure:

24 hours.

Observation period:

72 hours in total, with observations recorded at 24 and 72 hours.

Number of animals:

6 Rabbits.

Details on study design:

TEST SITE
- Area of exposure: Back and sides, a site to the left of the spinal column was abraded, while a site to the right of the spinal column was left intact.
- % coverage: no data
- Type of wrap if used: Surgical gauze, each site was a 1x1 area, two layers thick.


REMOVAL OF TEST SUBSTANCE
- Washing: No
- Time after start of exposure: N.A.


SCORING SYSTEM: Erythema and eschar formation and edema formation

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.25

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: Intact skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.5

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: Intact Skin

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: abraded skin

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.5

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: abraded skin

Results 5

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

2.79

Max. score:

8

Reversibility:

not specified

Remarks on result:

other: Abraded and intact skin

Irritant / corrosive response data:

The raw data is presented in table 1 and table 2 on the field "Remarks on results including tables and figures".

Any other information on results incl. tables

Table 1 - Erythema and eschar formation:

	Exposure time (Hours)	Rabbit No.						Mean score
		1	2	3	4	5	6
Intact skin	24	2	1	1	2	1	1	1.33
Abraded skin	24	1	1	1	2	2	1	1.33
Intact skin	72	1	2	0	2	1	1	1.17
Abraded skin	72	2	2	0	2	1	1	1.33

Table 2 - Edema formation:

	Exposure time (Hours)	Rabbit No.						Mean score
		1	2	3	4	5	6
Intact skin	24	2	2	2	2	2	2	2.00
Abraded skin	24	2	2	1	2	2	2	1.83
Intact skin	72	1	2	0	1	1	1	1.00
Abraded skin	72	2	2	0	1	1	1	1.17

Total sum of mean score (erythema + edema) = 11.16

Primary Dermal Irritation Index = Sum of Mean Scores/4 = 2.79

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information mmt is not classified as a skin irritant per EC/1272/2008.

Conclusions:

Although the primary dermal index score for mmt was 2.79., neither the erythema/eschar score nor the edema score exceeded the score of 2.3 in any animal. This score is necessary for classification under EC/1272/2008.

Executive summary:

In a primary dermal irritation study, six New Zealand rabbits were dermally exposed to 0.5 ml of unchanged mmt for 24 hours.  Animals were then observed for 72 hours. Irritation was scored by the method of OECD grading of skin reaction.

 

Although the primary dermal irritation index for erythema and oedema was 2.79, neither the erythema/eschar score nor the edema score exceeded the score of 2.3 necessary for classification under EC/1272/2008.