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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Old study conducted similarly to OECD Guideline 402 with minor deviations: few data about test substance and test conditions, skin was abraded.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Few data about test substance and test conditions, skin was abraded.
Principles of method if other than guideline:
Not applicable
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
7-methyl-3-methyleneocta-1,6-diene
EC Number:
204-622-5
EC Name:
7-methyl-3-methyleneocta-1,6-diene
Cas Number:
123-35-3
Molecular formula:
C10H16
IUPAC Name:
7-methyl-3-methylideneocta-1,6-diene
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.7 to 2.4 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
The test substance was applied at 5 g/kg bw on clipped abraded abdominal skin. The animals were wrapped with binders of rubber dam, gauze and adhesive tap.
Folllowing exposure, the binders were removed and observations were made.
Duration of exposure:
24 hours
Doses:
5 g/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed frequently for mortality for 14 days. Body weights were recorded at pre and post-treatment.
- Necropsy of survivors performed: Yes
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
other: No evidence of systemic toxicity. Signs of irritation were noted (see table 1).
Gross pathology:
No abnormalities were noted upon gross necropsy.
Other findings:
None

Any other information on results incl. tables

Table 1: signs of dermal irritation in rabbits following a 24-h exposure with myrcene

Observation day

Erythema

Edema

1

++ (8) + (2)

++ (9) + (1)

2

++ (5) + (5)

++ (5) + (5)

3

++ (3) + (6)

++ (3) + (6)

4

++ (1) + (7)

++ (2) + (6)

5

+ (5)

+ (4)

6

-

+ (2)

7

-

-

8

-

-

9

-

-

10

-

-

11

-

-

12

-

-

13

-

-

14

-

-

+ : slight ; ++ : moderate ; number in parentheses = number of animals showing sign

Table 2: bodyweights before and after treatment

Animal number

Pre-treatment (kg)

Post-treatment (kg)

1

2.0

1.9

2

1.7

1.8

3

1.9

2.0

4

2.0

1.9

5

2.4

2.4

6

2.0

2.0

7

1.8

1.8

8

2.1

2.0

9

2.2

2.1

10

2.2

2.2

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of myrcene was greater than 5 g/kg bw.
Executive summary:

In an acute dermal toxicity study performed similarly to OECD guideline 402, a group of 10 New Zealand White rabbits received a single dermal dose of myrcene at 5 g/kg on clipped abraded abdominal skin in occlusive conditions for 24 h. All animals were observed for mortality and skin reactions for 14 days. No mortality was observed. No changes in bodyweight related to treatment could be observed. No signs of systemic toxicity were observed. All animals showed slight to moderate erythema and edema during the first days after exposure that were completely reversed after 7 days.No abormalities were noted upon gross necropsy. Therefore, the acute dermal LD50 was greater than 5 g/kg bw.