1,4-naphthoquinone

Specific investigations: other studies

Administrative data

Endpoint:

specific investigations: other studies

Remarks:

Alarie test for respiratory irritation

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Justification for type of information:

Study included as a supporting study to support Classification and Labelling and is not considered as reliable for REACH purposes as the full experimental report is not available.

Cross-reference

Reason / purpose for cross-reference:

other: consideration of study for C&L

Reference

An in vivo dermal irritation study is available for the substance which indicates that the substance is corrosive to skin. As such, no in vitro or in vivo eye irritation/corrosion studies are considered necessary as the substance would be deemed corrosive. An Alarie test which can be used to assess the potential for respiratory irritation is also available.

Endpoint conclusion:

adverse effect observed (corrosive)

Endpoint conclusion:

no study available

Endpoint conclusion:

adverse effect observed (irritating)

In an available in vivo dermal irritation study, the test substance caused corrosive effects (necrosis) after a 4 hour exposure period which was observed 1 hour after exposure. No corrosive effects were observed after a 3 minute and 1 hour exposure period (observed 1 hour following the exposures). Accordingly, classification as Skin Corrosion Category 1C (H314) is deemed appropriate based on UN GHS and the CLP regulation (EC No. 1272/2008, as amended).

As the substance is deemed to be corrosive to skin, the relevant eye irritation/corrosion studies were not conducted as the hazard statement, however, the classification of Eye Damage 1. (H318) is automatically applied due the assignment of Skin Corrosion Cat. 1C (H314) to this substance.

In a guideline Alarie test an RD50 value of 0.0038 mg/L was obtained for the early phase of exposure. Although this study was not deemed adequate or required for REACH purposes, evidence of respiratory irritation was noted and a conservative classification as STOT SE 3 (H335) is applied.

Data source

Reference

Reference Type:

review article or handbook

Title:

1,4-Naphthoquinone - BUA Report 211 (October 1998)

Author:

GDCh-Advisory Committee on Existing Chemicals (BUA)

Year:

1998

Bibliographic source:

S.Hirzel Verlag Stuttgart; Wissenschaftliche Verlags-Gesellschaft Stuttgart, 2000 , ISBN3-7776-1064-X

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: ASTM E981-84

Deviations:

not specified

GLP compliance:

yes

Type of method:

in vivo

Endpoint addressed:

respiratory irritation

Test material

Test material information

Constituent 1

Reference substance name:

1,4-naphthoquinone

EC Number:

204-977-6

EC Name:

1,4-naphthoquinone

Cas Number:

130-15-4

Molecular formula:

C10H6O2

IUPAC Name:

1,4-naphthoquinone

Test material form:

solid

Test animals

Species:

mouse

Strain:

CD-1

Sex:

male

Administration / exposure

Route of administration:

inhalation

Vehicle:

air

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

30 minutes exposure

Frequency of treatment:

Early phase (3 to 10 minutes) and late phase (23 to 30 minutes) exposure period where whole body plethysmography was used. At the highest dose the duration of exposure was extended to 1 hour to detect possible damage to the deeper airways and the relative lung weights were determined 24 hours later.

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0 mg/L air

Doses / concentrations 2

Dose / conc.:

0.003 mg/L air

Doses / concentrations 3

Dose / conc.:

0.009 mg/L air

Doses / concentrations 4

Dose / conc.:

0.018 mg/L air

No. of animals per sex per dose:

4 males per group

Control animals:

yes

Examinations

Examinations:

Whole body plethysmography was used to record respiratory frequency. The RD50 value was determined which is the concentration which reduces respiration rate by 50%. Absolute and relative lung weights were also determined.

Positive control:

Yes although not used on study. The RD50 value for toluene diisocyanate was 1.4 µg/L air.

Results and discussion

Details on results:

The obtained RD50 value in the conducted Alarie test was 0.0038 mg/L for the early phase of exposure and 0.0051 mg/L for the late phase of exposure. At the high concentration the rate of respiration showed no recovery over an observation period of 10 minutes whilst at the intermediate and low concentrations recovery was around 50%. The absolute and relative lung weights were significantly increased at the highest concentration although no treatment-related histological effects were noted. Lethargy and exaggerated breating movements were also noted.

Applicant's summary and conclusion

Conclusions:

The obtained RD50 value in the conducted Alarie test was 0.0038 mg/L for the early phase of exposure and 0.0051 mg/L for the late phase of exposure. Evidence of respiratory irritation was obtained.