Refractories, fibers, aluminosilicate

Endpoint summary

Description of key information

Testing for skin irritation has proved negative.Due to the nature of the substance it is scientifically and ethically unjustified to perform an eye irritation study.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Remarks:

Negative results in skin irritation studies in animals and no positive results in humans result in non classification for irritancy and corrosion.In accordance with 31st Adaptation to Technical Progress (ATP) of Directive 67/548/ECC

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

Chopped fibre in water

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival limited Moston Sandbach Cheshire
- Age at study initiation:12-16 weeks
- Weight at study initiation:234-253 kg
- Housing: Individually housed in suspended metal cages
- Diet (e.g. ad libitum):Spillers rabbit diet
- Water (e.g. ad libitum):mains drinking water
- Acclimation period:5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):18-22
- Humidity (%):52-57
- Air changes (per hr):approx 15
- Photoperiod (hrs dark / hrs light):12hour cycle

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0.5g/rabbit

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

Chopped fibre applied on to the shorn skin and held in place with a semi occlusive dressing. The site examined at 1,24,48,72 hours

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1 hr

Score:

ca. 0

Max. score:

1

Reversibility:

fully reversible within: 24hours

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

no irritation or corrosion observed

Other effects:

none

Table 1 - RCF : Acute Dermal irritation test in rabbit - individual daily and individual mean scores for dermal irritation following 4 hour exposure

Skin Reaction	Reading (hours)	Individual scores – rabbit number and sex (body weight kg)
		191 female (2.28)	199 male (2.46)	201 male (2.89)
Erythema/Eschar formation	24 48 72	0 0 0	1 0 0	0 0 0
Total		0	1	0
Mean Score		0.0	0.3	0.0
Oedema formation	24 48 72	0 0 0	0 0 0	0 0 0
Total		0	0	0
Mean Score		0.0	0.0	0.0

Interpretation of results:

other:

Remarks:

Negative results in skin irritation studies in animals and no positive results in humans result in non classification for irritancy and corrosion.In accordance with 31st Adaptation to Technical Progress (ATP) of Directive 67/548/ECC

Conclusions:

The test article could not be classified as irritant

Executive summary:

There is no reason to classify this material as irritant nor corrosive.

This was confirmed with 31st Adaptation to Technical Progress (ATP) of Directive 67/548/ECC as published 15th January 2009 as the classification as “irritant” was removed for all types of man made vitreous fibres (MMVFs). .

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

GLP compliance:

yes

Species:

human

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Reconstructed human like epithelium

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

50mg solid

Duration of treatment / exposure:

6hours+/- 15 mins

Duration of post- treatment incubation (in vitro):

18hours+/- 15 mins

Number of animals or in vitro replicates:

2

Details on study design:

- Details of the test procedure used
- RhCE tissue construct used, including batch number
- Doses of test chemical and control substances used
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods (where applicable)
- Description of any modifications to the test procedure
- Indication of controls used for direct MTT-reducers and/or colouring test chemicals (if applicable)
- Number of tissue replicates used per test chemical and controls (positive control, negative control, NSMTT, NSCliving and NSCkilled, if applicable)
- Wavelength and band pass (if applicable) used for quantifying MTT formazan, and linearity range of measuring device (e.g. spectrophotometer)
- Description of the method used to quantify MTT formazan
- Description of the qualification of the HPLC/UPLC-spectrophotometry system (if applicable)
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model
- Reference to historical positive and negative control results demonstrating suitable run acceptance criteria
- Complete supporting information for the specific RhCE tissue construct used
- Reference to historical data of the RhCE tissue construct
- Demonstration of proficiency in performing the test method before routine use by testing of the proficiency chemicals
- Positive and negative control means and acceptance ranges based on historical data
- Acceptable variability between tissue replicates for positive and negative controls
- Acceptable variability between tissue replicates for the test chemical

Irritation parameter:

in vitro irritation score

Run / experiment:

expected

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Ocular irritation prediction

According to OECD guidelines and GHS classification, an irritant is predicted if the mean relative tissue viability of two individual tisues exposed to the test substance is <=60% of the mean viability of the negative controls.

In vitro result	GHS Classification
Mean tissue viability less than or equal to 60%	Category 1 or 2
Mean tissue viability greater than 60%	No category

 

The summarised results and irritation classification are as follows:

Test and Control Article identity	Tissue Viability		Irritancy classification	GHS Classification
	Mean	Diff.
Refractory ceramic fibre (RCF) - Aluminosilicate wool	105.4%	5.38%	Non-irritant	No Category
Tissue Culture water (negative control)	100.0%	2.67%	Non-irritant	No Category
Methyl acetate (positive control)	36.0%	6.03%	Irritant	Category 1 or 2

 

Diff = difference between the tissues

Interpretation of results:

other: Classed as non irritating

Conclusions:

substance is confirmed to be not irritatiing and as such is not classified as an irritant

Executive summary:

Substance was confirmed as non irritating

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Although negative results have only been obtained for skin, inhalation exposures using the nose only route produce simultaneous heavy exposures to the eyes and there are no reports of excess eye irritation . Animals exposed by inhalation similarly show no evidence of respiratory tract irritation. Human data has confirmed that only mechanical irritation occurs in humans resulting in itching of the skin. Screening at manufacturers’ plants in the UK has not revealed any cases of skin conditions in workers related to fibre exposure. The study report is detailed in section 7.10.1

Justification for classification or non-classification

Negative results in skin irritation studies in animals and no positive results in humans result in non classification for irritancy and corrosion.In accordance with 31st Adaptation to Technical Progress (ATP) of Directive 67/548/ECC as published 15th January 2009 the classification as “irritant” has been removed for all types of man made vitreous fibres (MMVFs).