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Administrative data

Description of key information

The test substance is not irritating to skin or eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
non-GLP
Qualifier:
according to guideline
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.41
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
NZW Albino Rabbits
Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal
Food: mümmel Z ad libitum
Supplier: sniff Spezialdiaten GmbH, Soest/Westfal
Water: Tap water ad libitum
Single housing
Weight: mean 2.6 kg

ENVIRONMENTAL CONDITIONS
- Temperature: 16-18°C
- Humidity: approx. 40 %
- Lighting time: 12 hours daily

Type of coverage:
occlusive
Preparation of test site:
clipped
Remarks:
right flank additionally scarified
Vehicle:
other: pasted with water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
24 hours
Observation period:
8 days
Number of animals:
6
Details on study design:
TEST SITE
- Preparation: about 24h before the start of the study the skin on the flanks of 6 rabbits was depilated on both sides of the body on an area of approximately 8 x 8 cm using electric
clippers. The skin on the right flank at the test patch application site was additionally scarified using a scarifier.
- Area of exposure: 2.5 x 2.5 cm, covered with medical gauze and indifferent, impermeable PVC foils (5 x 5 cm)
- Type of wrap if used: Eloflex as elastic bandage


REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours


SCORING SYSTEM: according to the score of Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 hours, 8 days
Score:
0
Max. score:
4
Remarks on result:
not determinable
Remarks:
discolouration of skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 hours
Score:
0.25
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Remarks:
clipped skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Remarks:
scarified skin
Irritant / corrosive response data:
No signs of systemic toxicity were observed during the observation period
Interpretation of results:
GHS criteria not met
Conclusions:
In the experimental conditions the test item is detemined to be not irritating to the skin.
Executive summary:

In the primary skin irritation test according to the Code of Federal Regulations, Title 16, Section 1500.41 the test item produced a primary irritation score of about 0.3. Due to substance-related coloration of the skin slight erythema could not be detected if apparent. Thus, the product is assassed to be non-irritant to the skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
no GLP
Qualifier:
according to guideline
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.42
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
NZW Albino Rabbits
Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal
Food: mümmel Z ad libitum
Supplier: sniff Spezialdiaten GmbH, Soest/Westfal
Water: Tap water ad libitum
Single housing
Weight: mean 2.5 kg

ENVIRONMENTAL CONDITIONS
- Temperature: 16-18°C
- Humidity: approx. 40 %
- Lighting time: 12 hours daily

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 µL bulk volume
Duration of treatment / exposure:
24 hours
no rinsing after treatment period
Observation period (in vivo):
The eyes were examined 24, 48, 72 hours, and 8 days after application of the test substance.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure:

TOOL USED TO ASSESS SCORE: opthalmoscope
on day 8: fluorescein; investigation under UV light or conalt blue filter after instillation of one drop of fluorescein-sodium solution and rinsing with physiological saline


SCORING SYSTEM: Draize

Evaluation
Evaluation covered pathological findings in the cornea (degree of opacity and area •affected), iris and conjunctivae (reddening, swelling and discharge). Evaluation details were based on the key given below, which was used to determine the irritation score.

Assessment key
From : The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, 1959, p.51 (see below)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
other: Lacrimation
Basis:
mean
Time point:
24/48/72 h
Score:
0.75
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24/48/72 h
Score:
1.7
Max. score:
110
Interpretation of results:
GHS criteria not met
Conclusions:
Testing for primary eye irritation in the rabbit showed that the substance is not irritating to eyes.
Executive summary:

100 µL of the test item was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control.

The treated eyes were examined 24, 48 and 72 hours and 8 days after application of the test substance.

At 8 days the eyes were also examined for corneal lesions under UV light after instillation of one drop of fluorescein.

No irritant effects were observed, hence the test substance is considered to be not irritating to the eye.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification