Z-85

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

2006-07-20 to 2006-08-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Physical state: tan coloured slightly viscous liquid
- Storage condition of test material: room temperature in the dark
- Other: Specific gravity = 1.004

See read-across justification in Section 13

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8-12 weeks old
- Weight at study initiation: at least 200 g
- Fasting period before study: none
- Housing: animals were housed in suspended solid-floor polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study
- Diet: Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK was provided ad libitum
- Water: tap water was available ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15/hour
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle.

IN-LIFE DATES: From: 2006-07-20 To: 2006-08-03

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: back and flanks
- % coverage: approximately 10 % of total body surface area
- Type of wrap if used: surgical gauze covered with self-adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with cotton wool moistened with distilled water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 mL/kg bw
- Concentration (if solution): the test material was used undiluted as supplied
- Constant volume or concentration used: yes
- For solids, paste formed: Not applicable

VEHICLE
- Amount(s) applied (volume or weight with unit): Not apllicable
- Concentration (if solution): Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days. Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: gross necropsies were performed on all animals after sacrifice at the conclusion of the 14 day observation period.

Statistics:

No data available

Results and discussion

Preliminary study:

Not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.
Male: Number of animals: 5; Number of deaths: 0
Female: Number of animals: 5; Number of deaths: 0

Clinical signs:

There were no signs of systemic toxicity.

Body weight:

All animals showed expected gains in bodyweight over the study period (Table 4 attached).

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

There were no signs of dermal irritation. Individual dermal reactions are given in Table 2 and 3 attached.

Any other information on results incl. tables

See attached document: Acute Dermal Toxicity Results

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test article, when administered as received to male and female Sprague-Dawley rats, had an acute dermal LD50 of greater than 2000 mg/kg bodyweight

Executive summary:

Test Guidance

OECD Guideline 402 (Acute Dermal Toxicity) and EC Method B3

Method and materials

In an acute dermal toxicity study, undiluted test material was applied to the shaved back and flanks of ten rats (5 males and 5 females) at a dose level of 2000 mg/kg bw. The test material was covered with a semi-occlusive dressing for a period of 24 hours. At the end of the exposure period any residual test material was removed and the animals were observed for 14 days.

Results

There were no deaths or clinical signs of toxicity during the study. Animals showed expected gains in bodyweight. There were no signs of dermal irritation. No abnormalities were observed at necropsy. The dermal LD50 of the test material in male and female rats has been determined to be greater than 2000 mg/kg bw.

Conclusion

In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for acute dermal toxicity