Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion:

Eye irritation (OECD 405, rabbit): not irritating

Key value for chemical safety assessment

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, according to accepted guidelines
Justification for type of information:
Please refer to the read-across justification document attached to section 13 in IUCLID.
Reference:
Composition 1
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Six rabbits were tested in total and three of the test eyes were washed following administration
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
reliability scoring based on 2002 guideline
Deviations:
yes
Remarks:
Six rabbits were tested in total and three of the test eyes were washed following administration
GLP compliance:
yes
Test material information:
Composition 1
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, D-2740 Bremervorde, Neuendamm 88
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: Individually
- Diet (e.g. ad libitum): ad libitum, Ssniff Mu Z (pellets), Ssniff Spezialdiaten GmbH
- Water (e.g. ad libitum): ad libitum, drinking water
- Acclimation period: At least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2°C
- Humidity (%): 50 to 85%
- Photoperiod (hrs dark / hrs light): 12/12


Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted

Duration of treatment / exposure:
0.1 mL of the test material was placed into the conjunctival sac of the left eye while the right eye served as control. On animal #4 to 6 the treated eye was washed out 4 seconds post-administration with 10 mL lukewarm water.
Observation period (in vivo):
1, 24, 48, and 72 hour
Number of animals or in vitro replicates:
6 animals in total
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washing was done in animals #4 to 6
- Time after start of exposure: 4 seconds after administration


SCORING SYSTEM:
Cornea opacity- degree of density (area most dense taken for reading): Grade

No ulceration or opacity: 0
Scattered or diffused areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible: 1
Easily discernible translucent areas, details of iris slightly obscured: 2
Nacreous areas, no details of iris visible, size of pupil barely discernible: 3
Opaque cornea, iris not discernible through the opacity: 4

Iris: Grade

Normal: 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light: 1
No reaction to light, haemorrhage, gross destruction (any or all of these): 2

Conjunctivae Redness (refers to the most severe reading of palpebral and bulbar conjunctivae, cornea, and iris): Grade

Blood vessels normal: 0
Some blood vessel definitely hyperaemic (injected): 1
Diffuse, crimson colour, individual vessels not easily discernible: 2
Diffuse beefy red appearance: 3

Chemosis (lids and/or nictating membranes): Grade

No swelling: 0
Any swelling above normal: 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half-closed: 3
Swelling with lids more than half-closed: 4


TOOL USED TO ASSESS SCORE: Readings of ocular reactions were made 1, 24, 48, 72 hours after treatment. The eyes were also examined for potential eye lesions at 24 and 72 hours post-administration by means of 1% fluorescein-dilution (1 drop/eye). It was washed out about 60 seconds post administration with sterile, non-pyrogenic, physiological saline.
Irritation parameter:
cornea opacity score
Basis:
other: mean animal 1
Time point:
other: 1, 24, 48, and 72
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
other: mean animal 2
Time point:
other: 1, 24, 48, and 72
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
other: mean animal 3
Time point:
other: 1, 24, 48, and 72
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
other: mean animal 1
Time point:
other: 1, 24, 48, and 72
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
other: mean animal 2
Time point:
other: 1, 24, 48, and 72
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
other: mean animal 3
Time point:
other: 1, 24, 48, and 72
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
other: mean animal 1
Time point:
other: 1, 24, 48, 72
Score:
0.5
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
other: mean animal 2
Time point:
other: 1, 24, 48, 72
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
other: mean animal 3
Time point:
other: 1, 24, 48, 72
Score:
1.25
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
other: mean animal 1
Time point:
other: 1, 24, 48, 72
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
other: mean animal 2
Time point:
other: 1, 24, 48, 72
Score:
0.75
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
other: mean animal 3
Time point:
other: 1, 24, 48, 72
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 24 hours

It should be noted that for the purposes of this dossier in accordance with OECD guidelines, results from individual animals in which the eyes were washed are not reported.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Irritation

Justification for read-across

There are no reliable data available regarding skin or eye irritation for 1-chloropropane (CAS 540-54-5). Read-across from an appropriate substance (2-chloropropane (CAS 75-29-6)) is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5. in order to fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VII, 8.1. Common functional groups, structural similarities and comparable toxicological properties (according to the joint consideration in Annex VI to CLP) of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

Skin irritation

CAS 75-29-6

The skin irritancy potential of 2-chloropropane (CAS 75-29-6) was determined in a skin irritation study performed according to OECD 404 and GLP (reference 7.3.1-1). The test substance was topically applied to the shaved skin of three rabbits (NZW) for 4 h. Local reactions were scored at 30 to 60 min, 24, 48 and 72 h after substance application. No local reactions were observed (meanerythema and edema scores of 0.0 calculated as mean for all animals over 24, 48 and 72 h). Based on the results of the conducted study, 2-chloropropane did not exhibit irritating properties towards the skin.

In conclusion, based on the analogue approach,1-chloropropane is not considered to be a skin irritant, which is in agreement to the harmonized classification according to Annex VI of CLP.

CAS 540-54-5

Limited data on skin irritation are available for 1-chloropropane (Jacobs et al., 1987). After topical application of 50% 1-chloropropane dissolved in sweet almond oil on the shaved rabbit skin for 4 hours, skin irritation was observed. As no further details on the results are available (e.g. Draize scores for different reading time points), the available data are not sufficient for a conclusive decision on classification and are therefore not considered for hazard assessment.

In conclusion, based on the available data and the read-across approach, 1-chloropropane is not considered to exhibit irritating properties towards the skin, which is in agreement to the harmonized classification according to Annex VI of CLP.

Eye irritation

CAS 75-29-6

To evaluate the irritation potential towards the eyes, 0.1 mL undiluted 2-chloropropane was instilled into the eyes of 6 white rabbits (NZW) (reference 7.3.2-1, study conducted according to OECD TG 405 and GLP). In 3/6 rabbits, residual test substance was removed from the eyes 4 seconds after administration by washing. The results obtained in these animals are not considered for hazard assessment. The reactions were scored 1, 24, 48 and 72 h after treatment. The animals with unwashed eyes showed marginal conjunctival redness and swelling, which were fully reversible latest within 48 h. No local reactions on the cornea or iris were observed.

Based on the results of the conducted study, 2-chloropropane is not considered to exhibit irritating properties towards the eyes.

In conclusion, based on the available data and the analogue approach, 1-chloropropane is not considered to be an eye irritant, which is in agreement to the harmonized classification according to Annex VI of CLP.

Justification for classification or non-classification

Based on the available data and the analogue approach, 1-chloropropane does not meet the classification criteria according to Regulation (EC) 1272/2008.