Registration Dossier

Administrative data

Description of key information

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
performed according to an official method by a renowned institution using "Diäthylcarbonat", no info about purity, origin or batch of the test substance, no GLP, no control animals, in general good documentation of methodology and evaluation of results
Qualifier:
according to
Guideline:
other: Code of Federal Regulations, Title 16, Section 1500.41
GLP compliance:
no
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: "Lippische Versuchstierzucht / Exertal 1"
- Sex: male
- Weight at study initiation: 2.3 kg (average)
- Housing: kept in single cages
- Diet ad libitum: "mümmel z"; English: "ssniff / Soest"
- Water ad libitum
- Acclimation period: 7-14 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18
- Humidity (%): 40
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To: no data
Type of coverage:
occlusive
Preparation of test site:
other: hair cut with electric hair cutter and not scarified/scarified with scarificator
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 microliter
Duration of treatment / exposure:
24 h
Observation period:
8 d; times of observation, after start of application of test substance: 24 h (detailed: 24.5 h), 48 h (data not reported), 72 h, 8d
Number of animals:
6
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h and 72 h
Score:
0.3
Reversibility:
other: no erythema at all; yes for edema
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h and 72 h
Score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
>= 0 - <= 2
Max. score:
2
Reversibility:
fully reversible within: until 72 h
Remarks on result:
other: single scores: 0, 1, 1, 1, 1, 2; not scarified
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
>= 0 - <= 1
Max. score:
1
Reversibility:
fully reversible within: until 72 h
Remarks on result:
other: single scores: 0, 0, 0, 1, 0, 0; scarified

8 d value with no valuation for irritation index as value was “0” for all six animals, scarified and non-scarified areas.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: conclusion in study report
Conclusions:
The test substance diethyl carbonate was not irritating to rabbit 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:
other: see 'Remark'
Remarks:
performed according to an official method by a renowned institution using "Diäthylcarbonat", no info about purity, origin or batch of the test substance, no GLP, no control animals, in general good documentation of methodology and evaluation of results
Qualifier:
according to
Guideline:
other: "Test for eye irritants", 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:
TEST ANIMALS
- Source: "Lippische Versuchstierzucht / Exertal 1"
- Sex: male
- Weight at study initiation: 2.3 kg (average)
- Housing: kept in single cages
- Diet ad libitum: "mümmel z"; English: "ssniff / Soest"
- Water ad libitum
- Acclimation period: 7-14 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-18
- Humidity (%): 40
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To: no data
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 microliter
Duration of treatment / exposure:
8 d (at no stage flushing of eye after substance was applied)
Observation period (in vivo):
8 d; times of observation, after application of test substance: 24 h, 48 h, 72 h, 8d
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing/flushing: not done

SCORING SYSTEM:
Irritation parameter:
cornea opacity score
Time point:
72 h
Score:
0
Irritation parameter:
iris score
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Time point:
72 h
Score:
0
Irritant / corrosive response data:
Results of the test

(1)Cornea
(A) : 0 for all 6 animals after 24, 48, 72 h and 8 d
(B) : 0 for all 6 animals after 24, 48, 72 h and 8 d
(2)Iris
(A) : 0 for all 6 animals after 24, 48, 72 h and 8 d
(3)Conjunctiva
(A) : 0, 0, 0, 0, 1, 1 after 24 h; 0, 0, 0, 0, 0, 1 after 48 h; 0 for all 6 animals after 72 h and 8 d
(B) : 0 for all 6 animals after 24, 48, 72 h and 8 d
(C) : 0 for all 6 animals after 24, 48, 72 h and 8 d

24 h values, sums of a+b+c: 0, 0, 0, 0, 2, 2
48 h values, sums of a+b+c: 0, 0, 0, 0, 0, 2
72 h values, sums of a+b+c: 0, 0, 0, 0, 0, 0

Primary irritation value = (15*0 + 2 + 2 + 2) / 18 = 0.3
Classification: 0 – 10 = not irritating
On a scale of 0-110 for primary eye irritation, the substance has reached 0.3 in the present study and will therefore be classified as not irritating.

8d results not included in the calculation of irritation index. All values were zero.

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: conclusion in study report
Conclusions:
The test substance diethyl carbonate was not irritating to the rabbits eye.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
The study was performed according to an official method (Code of Federal Regulations, Title 16, Section 1500.41).

Justification for selection of eye irritation endpoint:
The study was performed according to an official method ("Test for eye irritants", Code of Federal Regulations, Title 16, Section 1500.42).

Justification for classification or non-classification

The test substance diethyl carbonate was not irritating to rabbit skin (see endpoint record 7.3.1.001, study report, Saltigo, key data) as well as not irritating to the rabbits eye (see endpoint record 7.3.2.001, study report, Saltigo, key data). According to these results there is no need to perform a respiratory irritation test.